ferric carboxymaltose 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5128	53858-86-9

Description:

Molecule	Description
Synonyms: ferric carboxymaltose injectafer iron dextri-maltose ferinject	effective for treatment of postpartum anemia Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

ferric carboxymaltose
injectafer
iron dextri-maltose
ferinject

effective for treatment of postpartum anemia

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
July 25, 2013	FDA	LUITPOLD
March 26, 2019	PMDA	ZERIA PHARMACEUTICAL CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hypophosphataemia	1831.00	24.17	446	14896	10980	63462700
Anhedonia	629.72	24.17	191	15151	10783	63462897
Product quality issue	564.16	24.17	239	15103	35626	63438054
Emotional distress	449.76	24.17	198	15144	32351	63441329
Infusion site discolouration	332.16	24.17	69	15273	788	63472892
Urticaria	316.20	24.17	285	15057	165517	63308163
Maternal exposure during pregnancy	290.08	24.17	309	15033	219753	63253927
Blood phosphorus decreased	211.02	24.17	67	15275	4386	63469294
Flushing	207.09	24.17	160	15182	74927	63398753
Pruritus	189.92	24.17	324	15018	361129	63112551
Myalgia	186.06	24.17	202	15140	146327	63327353
Partner stress	185.21	24.17	38	15304	406	63473274
Drug ineffective	181.01	24.17	21	15321	1044744	62428936
Anxiety	179.70	24.17	241	15101	217300	63256380
Tachycardia	169.72	24.17	174	15168	117982	63355698
Extravasation	169.62	24.17	49	15293	2323	63471357
Infusion site extravasation	162.06	24.17	69	15273	10357	63463323
Dyspnoea	159.87	24.17	432	14910	660881	62812799
Chest discomfort	154.40	24.17	160	15182	109809	63363871
Nausea	151.55	24.17	500	14842	853971	62619709
Skin discolouration	143.87	24.17	98	15244	37730	63435950
Dizziness	121.15	24.17	298	15044	429627	63044053
Serum ferritin increased	93.04	24.17	40	15302	6142	63467538
Headache	85.62	24.17	340	15002	632901	62840779
Chest pain	82.22	24.17	169	15173	215790	63257890
Circulatory collapse	81.40	24.17	56	15286	21882	63451798
Respiratory distress	77.84	24.17	65	15277	33886	63439794
Osteomalacia	74.40	24.17	20	15322	725	63472955
Infusion site pain	72.05	24.17	47	15295	16822	63456858
Exposure during pregnancy	70.43	24.17	131	15211	155416	63318264
Anaphylactic reaction	69.90	24.17	83	15259	66017	63407663
Paraesthesia	68.34	24.17	130	15212	156836	63316844
Palpitations	68.19	24.17	108	15234	112662	63361018
Iron overload	66.35	24.17	19	15323	872	63472808
Erythema	65.04	24.17	136	15206	175615	63298065
Pneumonia	63.77	24.17	16	15326	456751	63016929
Asthenia	59.07	24.17	215	15127	383389	63090291
Suspected product quality issue	58.26	24.17	13	15329	212	63473468
Throat tightness	57.77	24.17	48	15294	24839	63448841
Feeling hot	56.17	24.17	65	15277	50289	63423391
Hyperventilation	52.94	24.17	27	15315	6089	63467591
Angioedema	51.97	24.17	61	15281	47904	63425776
Complication of pregnancy	49.68	24.17	14	15328	606	63473074
Throat irritation	49.56	24.17	53	15289	37594	63436086
Nasopharyngitis	49.49	24.17	3	15339	254254	63219426
Anaphylactoid reaction	49.24	24.17	22	15320	3701	63469979
Drug intolerance	48.87	24.17	8	15334	308653	63165027
Product preparation error	47.29	24.17	25	15317	6067	63467613
Malaise	47.14	24.17	212	15130	415742	63057938
Alopecia	46.73	24.17	12	15330	337524	63136156
Presyncope	45.48	24.17	44	15298	27741	63445939
Joint swelling	42.84	24.17	13	15329	327653	63146027
Muscle spasms	42.42	24.17	107	15235	156043	63317637
Product dose omission issue	42.11	24.17	4	15338	234309	63239371
Pain	42.10	24.17	314	15028	740314	62733366
Rheumatoid arthritis	41.49	24.17	6	15336	253813	63219867
Bronchospasm	39.42	24.17	33	15309	17247	63456433
Vomiting	39.29	24.17	250	15092	559367	62914313
Drug hypersensitivity	37.69	24.17	14	15328	310673	63163007
Chills	37.61	24.17	84	15258	113294	63360386
Back pain	37.20	24.17	144	15198	264001	63209679
Hyperhidrosis	37.02	24.17	81	15261	107755	63365925
Fibroblast growth factor 23 increased	36.64	24.17	5	15337	0	63473680
Systemic lupus erythematosus	36.41	24.17	4	15338	208914	63264766
Influenza like illness	36.29	24.17	61	15281	66763	63406917
Death	36.12	24.17	23	15319	374358	63099322
Hypotension	35.48	24.17	145	15197	272459	63201221
Arthropathy	35.17	24.17	7	15335	234785	63238895
Fall	34.05	24.17	27	15315	392307	63081373
Cold sweat	33.86	24.17	26	15316	12021	63461659
Weight decreased	32.69	24.17	13	15329	276785	63196895
Abdominal discomfort	31.93	24.17	19	15323	320866	63152814
Acute kidney injury	31.72	24.17	12	15330	263403	63210277
Pallor	31.66	24.17	38	15304	30530	63443150
Loss of consciousness	30.05	24.17	79	15263	118042	63355638
Abdominal pain	29.81	24.17	145	15197	293311	63180369
Weight increased	29.58	24.17	13	15329	260779	63212901
Therapeutic product effect decreased	28.43	24.17	6	15336	193181	63280499
Sinusitis	27.83	24.17	10	15332	226643	63247037
Hyperphosphaturia	27.53	24.17	5	15337	26	63473654
Urine phosphorus increased	27.21	24.17	5	15337	28	63473652
Premature delivery	27.12	24.17	35	15307	30246	63443434
Ear swelling	26.90	24.17	11	15331	1490	63472190
Bradycardia foetal	26.75	24.17	8	15334	428	63473252
Bone pain	25.91	24.17	47	15295	54594	63419086
Infusion site swelling	25.11	24.17	20	15322	9750	63463930
Blood parathyroid hormone increased	25.10	24.17	13	15329	3025	63470655
Hepatic enzyme increased	24.71	24.17	9	15333	202319	63271361
Injection site discolouration	24.41	24.17	18	15324	7830	63465850

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hypophosphataemia	333.75	27.82	90	2552	10936	34943353
Osteomalacia	104.89	27.82	22	2620	895	34953394
Hypophosphataemic osteomalacia	72.70	27.82	12	2630	125	34954164
Blood phosphorus decreased	59.98	27.82	18	2624	3163	34951126
Fibroblast growth factor 23 increased	50.95	27.82	6	2636	0	34954289
Skin discolouration	46.54	27.82	24	2618	17821	34936468
Extravasation	45.82	27.82	13	2629	1877	34952412
Stress fracture	39.53	27.82	10	2632	933	34953356
Anhedonia	37.88	27.82	16	2626	7569	34946720
Foetal exposure during pregnancy	36.42	27.82	27	2615	38074	34916215
Product quality issue	36.22	27.82	20	2622	17015	34937274
Blood pressure decreased	31.25	27.82	28	2614	51487	34902802
Urine phosphorus increased	30.47	27.82	5	2637	50	34954239
Blood lactic acid decreased	29.41	27.82	5	2637	63	34954226

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hypophosphataemia	1345.55	21.57	367	13772	19546	79710703
Infusion site discolouration	341.41	21.57	65	14074	644	79729605
Product quality issue	294.66	21.57	136	14003	33804	79696445
Anhedonia	281.00	21.57	104	14035	14794	79715455
Urticaria	279.80	21.57	244	13895	184957	79545292
Maternal exposure during pregnancy	266.95	21.57	209	13930	136329	79593920
Blood phosphorus decreased	221.12	21.57	71	14068	6597	79723652
Flushing	203.05	21.57	149	13990	88119	79642130
Pruritus	199.80	21.57	294	13845	394354	79335895
Emotional distress	199.11	21.57	110	14029	39859	79690390
Infusion site extravasation	173.95	21.57	66	14073	10042	79720207
Chest discomfort	150.64	21.57	152	13987	137892	79592357
Nausea	147.65	21.57	436	13703	956760	78773489
Skin discolouration	138.88	21.57	88	14051	40946	79689303
Extravasation	137.01	21.57	43	14096	3707	79726542
Osteomalacia	136.57	21.57	35	14104	1445	79728804
Dyspnoea	127.78	21.57	386	13753	856639	78873610
Tachycardia	122.35	21.57	154	13985	177614	79552635
Partner stress	119.76	21.57	24	14115	316	79729933
Myalgia	112.44	21.57	151	13988	185490	79544759
Drug ineffective	110.75	21.57	28	14111	1080885	78649364
Exposure during pregnancy	97.01	21.57	104	14035	101028	79629221
Dizziness	89.53	21.57	249	13890	526192	79204057
Anxiety	87.01	21.57	157	13982	248355	79481894
Serum ferritin increased	74.73	21.57	36	14103	9811	79720438
Headache	73.36	21.57	268	13871	653504	79076745
Hypophosphataemic osteomalacia	72.46	21.57	16	14123	344	79729905
Paraesthesia	68.93	21.57	117	14022	176206	79554043
Infusion site pain	67.76	21.57	38	14101	14138	79716111
Chest pain	65.04	21.57	150	13989	282154	79448095
Malaise	64.59	21.57	212	13927	489657	79240592
Anaphylactic reaction	63.08	21.57	76	14063	83667	79646582
Toxicity to various agents	62.28	21.57	3	14136	421537	79308712
Erythema	62.07	21.57	128	14011	223162	79507087
Respiratory distress	61.27	21.57	63	14076	58276	79671973
Throat tightness	59.35	21.57	45	14094	27862	79702387
Fibroblast growth factor 23 increased	56.08	21.57	8	14131	7	79730242
Product preparation error	55.85	21.57	25	14114	5768	79724481
Feeling hot	54.74	21.57	60	14079	59674	79670575
Throat irritation	53.81	21.57	50	14089	40896	79689353
Hyperhidrosis	52.03	21.57	95	14044	151397	79578852
Circulatory collapse	51.44	21.57	47	14092	37621	79692628
Anaphylactoid reaction	51.00	21.57	23	14116	5399	79724850
Angioedema	50.83	21.57	65	14074	75970	79654279
Pneumonia	47.87	21.57	29	14110	660217	79070032
Vomiting	46.03	21.57	236	13903	665592	79064657
Hyperventilation	45.61	21.57	24	14115	7875	79722374
Bronchospasm	44.05	21.57	36	14103	24823	79705426
Suspected product quality issue	41.87	21.57	10	14129	307	79729942
Urine phosphorus increased	41.67	21.57	8	14131	83	79730166
Presyncope	40.70	21.57	43	14096	41011	79689238
Hyperphosphaturia	39.80	21.57	8	14131	107	79730142
Iron overload	38.78	21.57	14	14125	1850	79728399
Influenza like illness	38.33	21.57	55	14084	71652	79658597
Palpitations	38.02	21.57	75	14064	126535	79603714
Back pain	35.89	21.57	127	14012	304053	79426196
Drug intolerance	35.65	21.57	3	14136	264116	79466133
Loss of consciousness	35.10	21.57	86	14053	167857	79562392
Infusion site swelling	34.76	21.57	20	14119	7806	79722443
Acute kidney injury	34.65	21.57	25	14114	519379	79210870
Death	34.37	21.57	30	14109	566484	79163765
Abdominal pain	34.08	21.57	148	13991	389421	79340828
Hypersensitivity	34	21.57	113	14026	262126	79468123
Blood pressure decreased	33.65	21.57	62	14077	99404	79630845
Infusion related reaction	33.29	21.57	103	14036	230134	79500115
Cold sweat	32.96	21.57	27	14112	18672	79711577
Hypotension	32.40	21.57	159	13980	440158	79290091
Premature delivery	31.49	21.57	29	14110	23438	79706811
Pallor	30.65	21.57	41	14098	50021	79680228
Chills	30.29	21.57	79	14060	160155	79570094
Injection site discolouration	29.99	21.57	18	14121	7596	79722653
Weight decreased	28.01	21.57	14	14125	355184	79375065
Bradycardia foetal	27.21	21.57	6	14133	128	79730121
Product preparation issue	27.14	21.57	10	14129	1400	79728849
Muscle spasms	26.96	21.57	80	14059	174650	79555599
Pigmentation disorder	26.68	21.57	15	14124	5603	79724646
Ear swelling	25.73	21.57	10	14129	1621	79728628
Nasopharyngitis	25.04	21.57	7	14132	253874	79476375
Hypocalcaemia	24.80	21.57	37	14102	49887	79680362
Confusional state	24.38	21.57	13	14126	317984	79412265
Blood parathyroid hormone increased	24.35	21.57	12	14127	3433	79726816
Laryngeal oedema	23.96	21.57	16	14123	8113	79722136
Administration site extravasation	23.93	21.57	9	14130	1334	79728915
Asthenia	23.42	21.57	163	13976	511526	79218723
Calciphylaxis	23.33	21.57	12	14127	3758	79726491
Weight increased	23.31	21.57	10	14129	277376	79452873
Premature rupture of membranes	22.46	21.57	12	14127	4057	79726192
Rheumatoid arthritis	22.00	21.57	5	14134	208465	79521784
Drug hypersensitivity	21.79	21.57	13	14126	298903	79431346
Transferrin saturation decreased	21.59	21.57	8	14131	1138	79729111

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

None

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Iron deficiency anemia	indication	87522002

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11123321	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11291645	Oct. 20, 2023	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11590097	Oct. 20, 2023	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11364260	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WEIGHING AT LEAST 46.7 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN LESS THAN 15 MINUTES
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.7 G OF IRON IN 15 MINUTES
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 46.7 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN < 15 MINUTES
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6 GRAMS OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY ADMINISTERING IV AT LEAST ABOUT 0.6 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON IN ABOUT ≤ 15 MIN
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11364260	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WEIGHING AT LEAST 46.7 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN LESS THAN 15 MINUTES
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.7 G OF IRON IN 15 MINUTES
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 46.7 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN < 15 MINUTES
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6 GRAMS OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NON-IMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY ADMINISTERING IV AT LEAST ABOUT 0.6 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON IN ABOUT ≤ 15 MIN
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11364260	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WEIGHING AT LEAST 46.7 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN LESS THAN 15 MINUTES
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.7 G OF IRON IN 15 MINUTES
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 46.7 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN < 15 MINUTES
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6 GRAMS OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NON-IMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY ADMINISTERING IV AT LEAST ABOUT 0.6 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON IN ABOUT ≤ 15 MIN
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11364260	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WEIGHING AT LEAST 46.7 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN LESS THAN 15 MINUTES
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.7 G OF IRON IN 15 MINUTES
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11433091	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 46.7 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN < 15 MINUTES
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	11478502	Jan. 8, 2027	METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6 GRAMS OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NON-IMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY ADMINISTERING IV AT LEAST ABOUT 0.6 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	8895612	Jan. 8, 2027	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON IN ABOUT ≤ 15 MIN
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER HAVING INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER HAVING INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULTS WHO HAVE INTOLERANCE TO OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR A GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER HAVING INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULTS WHO HAVE INTOLERANCE TO OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR A GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER HAVING INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULTS WHO HAVE INTOLERANCE TO OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR A GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	7754702	Feb. 15, 2028	METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	April 28, 2024	NEW STRENGTH
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	Nov. 19, 2024	NEW PATIENT POPULATION
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	Nov. 19, 2024	NEW PATIENT POPULATION
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	Nov. 19, 2024	NEW PATIENT POPULATION
100MG IRON/2ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Feb. 4, 2022	RX	SOLUTION	INTRAVENOUS	May 31, 2026	TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
1GM IRON/20ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	April 28, 2021	RX	SOLUTION	INTRAVENOUS	May 31, 2026	TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
500MG IRON/10ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	Oct. 8, 2020	RX	SOLUTION	INTRAVENOUS	May 31, 2026	TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
750MG IRON/15ML (50MG IRON/ML)	INJECTAFER	AM REGENT	N203565	July 25, 2013	RX	SOLUTION	INTRAVENOUS	May 31, 2026	TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY

Bioactivity Summary:

None

External reference:

ID	Source
1461680-64-7	SECONDARY_CAS_RN
D08920	KEGG_DRUG
4032651	VANDF
CHEMBL2108597	ChEMBL_ID
C522335	MESH_SUPPLEMENTAL_RECORD_UI
DB08917	DRUGBANK_ID
1433693	RXNORM
204720	MMSL
29586	MMSL
d07305	MMSL
012722	NDDF
430077004	SNOMEDCT_US
430819007	SNOMEDCT_US
C2001867	UMLSCUI
8853	INN_ID
86278165	PUBCHEM_CID
6897GXD6OE	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0602	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0602	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0602	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0620	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0620	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0620	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0620	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0650	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0650	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0650	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections
Injectafer	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0650	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	26 sections