estradiol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
estrogens	1057	50-28-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: estradiol 17Beta-Estradiol 17Beta-Oestradiol Beta-Estradiol estradiol hemihydrate	The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids. Molecular weight: 272.39 Formula: C18H24O2 CLOGP: 3.78 LIPINSKI: 0 HAC: 2 HDO: 2 TPSA: 40.46 ALOGS: -4.11 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

estradiol
17Beta-Estradiol
17Beta-Oestradiol
Beta-Estradiol
estradiol hemihydrate

The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.

Molecular weight: 272.39
Formula: C18H24O2
CLOGP: 3.78
LIPINSKI: 0
HAC: 2
HDO: 2
TPSA: 40.46
ALOGS: -4.11
ROTB: 0

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	mg	N
2	mg	O
1	mg	P
0.30	mg	P
5	mg	R
50	mcg	TD
1	mg	TD
1.53	mg	TD
25	mcg	V
7.50	mcg	V

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.09 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.84 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	5 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.70 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 23, 1975	FDA	BRISTOL MYERS SQUIBB

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
Product adhesion issue	4771.23	9.90	1222	87967	4275	53255602
Hot flush	1151.81	9.90	807	88382	46353	53213524
Application site rash	893.50	9.90	283	88906	2413	53257464
Application site erythema	570.24	9.90	240	88949	4851	53255026
Application site pruritus	530.46	9.90	215	88974	3934	53255943
Product quality issue	501.48	9.90	448	88741	36575	53223302
Product physical issue	478.03	9.90	214	88975	5048	53254829
Application site irritation	442.10	9.90	152	89037	1712	53258165
Meningioma	348.84	9.90	155	89034	3589	53256288
Wrong technique in product usage process	314.30	9.90	442	88747	59590	53200287
Vulvovaginal discomfort	299.79	9.90	121	89068	2188	53257689
Application site reaction	255.10	9.90	81	89108	696	53259181
Menopausal symptoms	216.11	9.90	93	89096	1988	53257889
Death	208.41	9.90	175	89014	357057	52902820
Vulvovaginal pain	206.56	9.90	94	89095	2305	53257572
Vaginal haemorrhage	179.60	9.90	223	88966	26618	53233259
Vulvovaginal burning sensation	174.55	9.90	76	89113	1673	53258204
Application site pain	173.07	9.90	100	89089	4083	53255794
Pneumonia viral	171.69	9.90	121	89068	6991	53252886
Breast tenderness	162.18	9.90	79	89110	2267	53257610
Toxicity to various agents	158.21	9.90	85	89104	219513	53040364
Device adhesion issue	157.89	9.90	90	89099	3580	53256297
Pemphigus	151.33	9.90	5	89184	104026	53155851
Blood oestrogen decreased	145.60	9.90	42	89147	250	53259627
Vulvovaginal dryness	141.91	9.90	73	89116	2359	53257518
Vaginal discharge	132.23	9.90	95	89094	5658	53254219
Application site vesicles	130.08	9.90	59	89130	1435	53258442
Postmenopausal haemorrhage	128.63	9.90	66	89123	2121	53257756
Application site urticaria	128.10	9.90	38	89151	253	53259624
Soft tissue disorder	127.44	9.90	83	89106	4207	53255670
Device material issue	122.98	9.90	34	89155	169	53259708
Completed suicide	121.10	9.90	40	89149	138161	53121716
Fibromyalgia	117.24	9.90	240	88949	43835	53216042
Product complaint	116.20	9.90	122	89067	12135	53247742
Colitis microscopic	114.57	9.90	95	89094	6999	53252878
Migraine	111.07	9.90	341	88848	80076	53179801
Application site burn	109.92	9.90	45	89144	845	53259032
Incorrect dose administered by product	109.21	9.90	30	89159	145	53259732
Ovarian hyperstimulation syndrome	108.14	9.90	70	89119	3511	53256366
Hand deformity	108.13	9.90	9	89180	84840	53175037
Product substitution issue	103.21	9.90	130	89059	15736	53244141
Glossodynia	101.11	9.90	22	89167	100269	53159608
Feeling abnormal	100.99	9.90	471	88718	134830	53125047
Acute kidney injury	96.52	9.90	173	89016	253695	53006182
Hormone level abnormal	95.36	9.90	56	89133	2357	53257520
Skin reaction	91.34	9.90	107	89082	12016	53247861
Night sweats	89.07	9.90	187	89002	34760	53225117
Febrile neutropenia	87.41	9.90	33	89156	104903	53154974
Neutropenia	85.45	9.90	84	89105	159101	53100776
Anti-cyclic citrullinated peptide antibody positive	82.24	9.90	3	89186	57169	53202708
Schizoaffective disorder	82.05	9.90	49	89140	2128	53257749
Skin irritation	80.45	9.90	84	89105	8300	53251577
Product dose omission issue	80.31	9.90	572	88617	191048	53068829
Systemic lupus erythematosus	79.87	9.90	56	89133	125358	53134519
Hysterectomy	77.23	9.90	83	89106	8478	53251399
Maternal exposure during pregnancy	75.88	9.90	89	89100	155550	53104327
Pancytopenia	71.81	9.90	31	89158	90897	53168980
Wound	71.06	9.90	32	89157	91525	53168352
Glaucoma	70.04	9.90	112	89077	16891	53242986
Intermenstrual bleeding	69.27	9.90	79	89110	8619	53251258
Vaginal infection	69.06	9.90	69	89120	6472	53253405
Vaginal odour	68.85	9.90	27	89162	451	53259426
Drug ineffective	68.75	9.90	1818	87371	815427	52444450
Headache	68.15	9.90	1267	87922	535554	52724323
Thrombocytopenia	67.98	9.90	79	89110	138648	53121229
Application site hypersensitivity	67.42	9.90	22	89167	208	53259669
Exposure during pregnancy	66.86	9.90	66	89123	124794	53135083
Vulvovaginal pruritus	64.30	9.90	45	89144	2570	53257307
Intentional overdose	61.44	9.90	18	89171	67187	53192690
Depression	61.43	9.90	519	88670	182533	53077344
Hyperkalaemia	60.95	9.90	9	89180	54247	53205630
Thyroid disorder	60.01	9.90	92	89097	13381	53246496
Oestrogen receptor assay positive	59.55	9.90	24	89165	432	53259445
Insomnia	59.43	9.90	524	88665	186548	53073329
Arthritis	59.38	9.90	296	88893	87002	53172875
Hypotension	58.95	9.90	222	88967	253854	53006023
Cardiac arrest	58.09	9.90	43	89146	93624	53166253
General physical health deterioration	57.72	9.90	98	89091	146844	53113033
Pyrexia	57.66	9.90	416	88773	402777	52857100
Blood cholesterol increased	57.35	9.90	207	88982	52782	53207095
Incorrect dose administered by device	56.33	9.90	47	89142	3492	53256385
Sepsis	56.29	9.90	99	89090	146330	53113547
Pericarditis	55.76	9.90	19	89170	64387	53195490
Rheumatoid arthritis	55.53	9.90	304	88885	314227	52945650
Cardiac failure	55.08	9.90	38	89151	85806	53174071
Contraindicated product administered	54.62	9.90	89	89100	135540	53124337
Diverticulitis	54.31	9.90	157	89032	35644	53224233
Herpes zoster	53.94	9.90	256	88933	73763	53186114
Salpingo-oophorectomy unilateral	53.90	9.90	25	89164	641	53259236
Application site scar	53.65	9.90	19	89170	235	53259642
Product shape issue	53.44	9.90	17	89172	147	53259730
Breast pain	52.84	9.90	67	89122	8162	53251715
Hyperhidrosis	52.82	9.90	309	88880	96484	53163393
Multiple organ dysfunction syndrome	52.59	9.90	14	89175	55663	53204214
Uterine haemorrhage	52.50	9.90	47	89142	3840	53256037
Product packaging issue	52.31	9.90	29	89160	1092	53258785
Incorrect dose administered	51.55	9.90	195	88994	50850	53209027
Arthropathy	51.38	9.90	99	89090	141354	53118523
Wrong technique in device usage process	51.10	9.90	39	89150	2548	53257329
Rheumatoid factor positive	50.78	9.90	5	89184	41193	53218684
Liver function test abnormal	50.51	9.90	186	89003	47885	53211992
Blood oestrogen increased	50.29	9.90	15	89174	102	53259775
Vaginal erosion	50.05	9.90	12	89177	29	53259848
Product availability issue	50.01	9.90	35	89154	1999	53257878
Application site erosion	49.63	9.90	17	89172	189	53259688
Respiratory failure	49.48	9.90	57	89132	100455	53159422
Drug abuse	49.15	9.90	24	89165	65502	53194375
No adverse event	49.14	9.90	161	89028	39104	53220773
Sinusitis fungal	48.91	9.90	30	89159	1368	53258509
Progesterone receptor assay positive	48.36	9.90	19	89170	319	53259558
Platelet count decreased	48.31	9.90	66	89123	108033	53151844
Cardio-respiratory arrest	48.05	9.90	19	89170	58739	53201138
Application site swelling	47.87	9.90	22	89167	552	53259325
Breast cancer	46.94	9.90	185	89004	49173	53210704
Disease progression	46.80	9.90	61	89128	101859	53158018
Bronchitis	46.80	9.90	334	88855	111565	53148312
Fungal infection	46.61	9.90	139	89050	32107	53227770
Mucosal inflammation	46.02	9.90	8	89181	42776	53217101
Breast enlargement	45.13	9.90	30	89159	1574	53258303
Oral pain	44.94	9.90	122	89067	26715	53233162
Breast cancer in situ	44.77	9.90	29	89160	1456	53258421
Butterfly rash	44.56	9.90	26	89163	1081	53258796
Application site discolouration	43.42	9.90	23	89166	790	53259087
Renal failure	42.06	9.90	84	89105	118368	53141509
Application site inflammation	41.85	9.90	18	89171	384	53259493
Duodenal ulcer perforation	41.51	9.90	5	89184	35178	53224699
Application site dermatitis	40.93	9.90	15	89174	206	53259671
Infusion related reaction	40.35	9.90	130	89059	155827	53104050
Sputum increased	40.33	9.90	32	89157	2214	53257663
Embolism venous	39.99	9.90	36	89153	2963	53256914
Malignant neoplasm progression	39.23	9.90	37	89152	71504	53188373
Product odour abnormal	38.74	9.90	25	89164	1247	53258630
Overdose	38.60	9.90	76	89113	107660	53152217
Helicobacter infection	38.50	9.90	9	89180	39060	53220817
Septic shock	38.02	9.90	29	89160	62200	53197677
Lactic acidosis	37.88	9.90	8	89181	37245	53222632
Respiratory symptom	37.71	9.90	33	89156	2616	53257261
Product size issue	37.23	9.90	17	89172	420	53259457
Vulvovaginal mycotic infection	37.06	9.90	43	89146	4779	53255098
Bladder prolapse	36.74	9.90	29	89160	1991	53257886
Uterine leiomyoma	36.72	9.90	58	89131	8654	53251223
Nasal polyps	36.32	9.90	34	89155	2942	53256935
Oestradiol increased	36.24	9.90	11	89178	80	53259797
Oestradiol decreased	36.13	9.90	9	89180	27	53259850
Renal impairment	36.10	9.90	52	89137	83266	53176611
Mood swings	36.05	9.90	86	89103	17400	53242477
Product packaging quantity issue	36.00	9.90	24	89165	1265	53258612
Muscle spasms	36.00	9.90	364	88825	134431	53125446
Blood creatinine increased	35.41	9.90	52	89137	82610	53177267
Fibrocystic breast disease	35.11	9.90	23	89166	1177	53258700
Application site exfoliation	34.54	9.90	15	89174	328	53259549
Haemoglobin decreased	34.45	9.90	116	89073	137191	53122686
Poor quality product administered	34.22	9.90	34	89155	3167	53256710
Dermatitis contact	34.20	9.90	57	89132	8895	53250982
Placenta accreta	33.95	9.90	13	89176	203	53259674
Breast cancer female	33.94	9.90	49	89140	6755	53253122
Hypothalamo-pituitary disorder	33.93	9.90	19	89170	730	53259147
Nipple pain	33.85	9.90	14	89175	270	53259607
Device use issue	33.52	9.90	27	89162	1909	53257968
Application site dryness	32.86	9.90	12	89177	163	53259714
Menopause	32.48	9.90	29	89160	2361	53257516
Endometrial cancer	32.25	9.90	32	89157	2976	53256901
Pneumonia	31.86	9.90	484	88705	406685	52853192
Hypoglycaemia	31.80	9.90	31	89158	58982	53200895
Anxiety	31.66	9.90	483	88706	196221	53063656
Therapeutic response unexpected	31.45	9.90	81	89108	17189	53242688
Bradycardia	31.12	9.90	44	89145	71012	53188865
Hyponatraemia	30.61	9.90	87	89102	108520	53151357
Endometrial hyperplasia	30.41	9.90	18	89171	769	53259108
Chronic sinusitis	29.93	9.90	43	89146	5902	53253975
Sleep disorder due to general medical condition, insomnia type	29.89	9.90	3	89186	24346	53235531
Anaemia	29.87	9.90	307	88882	276411	52983466
Product prescribing issue	29.75	9.90	21	89168	1216	53258661
Pleural effusion	29.60	9.90	65	89124	88514	53171363
Bone marrow failure	29.55	9.90	7	89182	30108	53229769
Endometrial cancer stage I	29.47	9.90	12	89177	222	53259655
Metabolic acidosis	29.43	9.90	17	89172	42225	53217652
Gastrointestinal haemorrhage	29.35	9.90	56	89133	80274	53179603
Osteopenia	29.30	9.90	82	89107	18273	53241604
Abdominal distension	29.29	9.90	231	88958	79559	53180318
Interstitial lung disease	29.11	9.90	33	89156	58589	53201288
Vitamin D decreased	28.68	9.90	52	89137	8677	53251200
Colitis ischaemic	28.65	9.90	59	89130	10815	53249062
Hepatic function abnormal	28.46	9.90	13	89176	36886	53222991
Ophthalmic vein thrombosis	28.36	9.90	10	89179	122	53259755
Endometrial stromal sarcoma	28.35	9.90	7	89182	20	53259857
Application site ulcer	28.28	9.90	10	89179	123	53259754
Vulvovaginal injury	28.01	9.90	14	89175	425	53259452
Lower respiratory tract infection	27.82	9.90	70	89119	90911	53168966
Female genital tract fistula	27.59	9.90	34	89155	4024	53255853
Suicide attempt	27.54	9.90	34	89155	58134	53201743
Cholestasis	27.51	9.90	7	89182	28688	53231189
Pseudoprecocious puberty	26.98	9.90	5	89184	0	53259877
Breast discomfort	26.94	9.90	14	89175	462	53259415
Vomiting	26.80	9.90	630	88559	496509	52763368
Hypokalaemia	26.70	9.90	78	89111	96439	53163438
Palpitations	26.65	9.90	275	88914	102073	53157804
Tinnitus	26.32	9.90	111	89078	30408	53229469
Therapeutic product effect increased	26.26	9.90	19	89170	1144	53258733
Diaphragmatic rupture	26.23	9.90	11	89178	220	53259657
Vision blurred	26.22	9.90	238	88951	85366	53174511
Rectal prolapse	26.02	9.90	23	89166	1848	53258029
Dyspareunia	25.96	9.90	26	89163	2445	53257432
Hypoxia	25.89	9.90	33	89156	55647	53204230
Treatment failure	25.51	9.90	119	89070	128284	53131593
Irritability	25.48	9.90	111	89078	30842	53229035
Dermal absorption impaired	25.17	9.90	6	89183	14	53259863
Influenza like illness	25.04	9.90	181	89008	60678	53199199
Atrial fibrillation	24.92	9.90	99	89090	111553	53148324
Dehydration	24.85	9.90	172	89017	168238	53091639
Diastolic dysfunction	24.76	9.90	39	89150	5805	53254072
Tachycardia	24.76	9.90	95	89094	108117	53151760
Dyspnoea	24.57	9.90	770	88419	585462	52674415
Spinal operation	24.54	9.90	41	89148	6410	53253467
Delirium	24.43	9.90	20	89169	41409	53218468
White blood cell count decreased	24.35	9.90	116	89073	124359	53135518
Carpal tunnel syndrome	24.18	9.90	75	89114	17692	53242185
Periodontal disease	24.17	9.90	21	89168	1649	53258228
Endometrial hypertrophy	24.08	9.90	11	89178	272	53259605
Libido decreased	23.97	9.90	26	89163	2683	53257194
Application site discomfort	23.96	9.90	12	89177	366	53259511
Altered state of consciousness	23.92	9.90	6	89183	24830	53235047
Skin burning sensation	23.82	9.90	57	89132	11553	53248324
International normalised ratio increased	23.59	9.90	27	89162	47734	53212143
Paraesthesia	23.22	9.90	320	88869	127195	53132682
Folliculitis	23.19	9.90	12	89177	31697	53228180
Fall	23.16	9.90	441	88748	357999	52901878
Neutrophil count decreased	22.93	9.90	29	89160	49069	53210808
Device breakage	22.90	9.90	53	89136	10514	53249363
Pregnancy	22.85	9.90	12	89177	31429	53228448
Abdominal discomfort	22.72	9.90	248	88941	220814	53039063
Application site discharge	22.54	9.90	9	89180	158	53259719
Eczema	22.47	9.90	90	89099	24092	53235785
Meniscus injury	22.32	9.90	40	89149	6615	53253262
Vessel puncture site bruise	22.10	9.90	11	89178	331	53259546
Vulvovaginal erythema	21.72	9.90	10	89179	252	53259625
Shock	21.51	9.90	6	89183	23133	53236744
Decreased appetite	21.37	9.90	243	88946	214731	53045146
Breast calcifications	21.31	9.90	17	89172	1185	53258692
Injection site inflammation	21.28	9.90	27	89162	3291	53256586
Normal tension glaucoma	21.19	9.90	7	89182	69	53259808
Spinal stenosis	21.16	9.90	62	89127	14179	53245698
Erythema of eyelid	20.99	9.90	21	89168	1973	53257904
Product colour issue	20.98	9.90	14	89175	739	53259138
Coma	20.92	9.90	45	89144	61738	53198139
Cardiac failure congestive	20.85	9.90	82	89107	92675	53167202
Stress	20.80	9.90	165	89024	56919	53202958
Breast mass	20.65	9.90	39	89150	6712	53253165
Heavy menstrual bleeding	20.62	9.90	70	89119	17306	53242571
Sopor	20.49	9.90	5	89184	21079	53238798
Pericardial effusion	20.44	9.90	10	89179	27268	53232609
Intestinal polyp	20.42	9.90	17	89172	1259	53258618
Drug reaction with eosinophilia and systemic symptoms	20.40	9.90	15	89174	32785	53227092
Respiratory distress	20.36	9.90	16	89173	33811	53226066
Photosensitivity reaction	20.35	9.90	60	89129	13768	53246109
Memory impairment	20.32	9.90	224	88965	84533	53175344
Histamine intolerance	20.22	9.90	6	89183	40	53259837
Diverticulum	20.17	9.90	54	89135	11725	53248152
Pituitary tumour	20.16	9.90	15	89174	943	53258934
Atypical haemolytic uraemic syndrome	19.93	9.90	12	89177	529	53259348
Change of bowel habit	19.73	9.90	20	89169	1908	53257969
Feeling hot	19.73	9.90	128	89061	41416	53218461
Sleep apnoea syndrome	19.71	9.90	91	89098	25911	53233966
Emotional disorder	19.62	9.90	57	89132	12973	53246904
Cystocele	19.30	9.90	16	89173	1178	53258699
Porphyria non-acute	19.27	9.90	10	89179	329	53259548
Ventricular dyskinesia	19.26	9.90	8	89181	156	53259721
Bone density abnormal	19.13	9.90	25	89164	3137	53256740
Pre-existing condition improved	19.13	9.90	42	89147	8047	53251830
Oxygen saturation decreased	19.11	9.90	65	89124	76660	53183217
Sinus rhythm	19.11	9.90	13	89176	709	53259168
Vaginal disorder	19.07	9.90	13	89176	711	53259166
Corticosteroid binding globulin increased	18.82	9.90	4	89185	4	53259873
Lymphogranuloma venereum	18.82	9.90	4	89185	4	53259873
Respiratory arrest	18.79	9.90	17	89172	33523	53226354
Confusional state	18.73	9.90	221	88968	194000	53065877
Lung disorder	18.72	9.90	32	89157	47847	53212030
Productive cough	18.65	9.90	42	89147	56687	53203190
Breast disorder	18.62	9.90	21	89168	2263	53257614
Acute respiratory failure	18.54	9.90	15	89174	31243	53228634
Incorrect product administration duration	18.49	9.90	49	89140	10575	53249302
Uterine polyp	18.22	9.90	19	89170	1874	53258003
Loss of personal independence in daily activities	18.18	9.90	58	89131	69757	53190120
Poor quality sleep	18.17	9.90	67	89122	17256	53242621
Device expulsion	18.07	9.90	14	89175	29799	53230078
Tricuspid valve incompetence	17.98	9.90	59	89130	14337	53245540
Application site laceration	17.93	9.90	4	89185	6	53259871
Rectocele	17.89	9.90	14	89175	949	53258928
Product administered at inappropriate site	17.88	9.90	22	89167	2600	53257277
Pneumocystis jirovecii pneumonia	17.75	9.90	3	89186	16375	53243502
Osteoarthritis	17.69	9.90	188	89001	70298	53189579
Palmar-plantar erythrodysaesthesia syndrome	17.64	9.90	7	89182	21599	53238278
Spider naevus	17.32	9.90	7	89182	127	53259750
Bacterial vulvovaginitis	17.21	9.90	12	89177	681	53259196
Amnesia	17.10	9.90	132	89057	45156	53214721
Drug resistance	17.08	9.90	6	89183	19956	53239921
Pelvic infection	17.05	9.90	9	89180	307	53259570
Gastrooesophageal reflux disease	16.94	9.90	212	88977	82451	53177426
Prosopagnosia	16.89	9.90	5	89184	33	53259844
Low density lipoprotein increased	16.89	9.90	34	89155	6132	53253745
Atrophic vulvovaginitis	16.86	9.90	17	89172	1612	53258265
Breast cyst	16.81	9.90	17	89172	1617	53258260
Acute respiratory distress syndrome	16.81	9.90	9	89180	23323	53236554
Periorbital oedema	16.63	9.90	31	89158	5284	53254593
Joint swelling	16.61	9.90	284	88905	234354	53025523
Burning sensation	16.53	9.90	137	89052	47876	53212001
Product taste abnormal	16.50	9.90	19	89170	2094	53257783
Intentional self-injury	16.47	9.90	11	89178	25273	53234604
Peritonitis	16.17	9.90	8	89181	21679	53238198
Condition aggravated	16.12	9.90	376	88813	296758	52963119
Surgery	16.12	9.90	100	89089	31864	53228013
Craniopharyngioma	16.08	9.90	7	89182	154	53259723
Vulvovaginal swelling	16.03	9.90	10	89179	470	53259407
Ovarian atrophy	15.95	9.90	6	89183	89	53259788
Vulvovaginal inflammation	15.80	9.90	11	89178	623	53259254
Hepatotoxicity	15.78	9.90	14	89175	27866	53232011
Abnormal dreams	15.60	9.90	46	89143	10555	53249322
Anosmia	15.58	9.90	27	89162	4348	53255529
Procedural pain	15.50	9.90	57	89132	14660	53245217
Aptyalism	15.44	9.90	10	89179	502	53259375
Therapeutic product effect decreased	15.41	9.90	135	89054	125520	53134357
Product physical consistency issue	15.33	9.90	10	89179	508	53259369
Bone density decreased	15.33	9.90	47	89142	11017	53248860
Procedural anxiety	15.32	9.90	11	89178	654	53259223
Swelling	15.30	9.90	226	88963	190879	53068998
Breast swelling	15.19	9.90	14	89175	1188	53258689
Muscle fatigue	14.99	9.90	19	89170	2314	53257563
Suspected product quality issue	14.90	9.90	7	89182	185	53259692
Breast engorgement	14.89	9.90	6	89183	108	53259769
Crying	14.78	9.90	75	89114	22187	53237690
Neoplasm progression	14.68	9.90	17	89172	29902	53229975
Product outer packaging issue	14.62	9.90	4	89185	19	53259858
Diarrhoea	14.58	9.90	877	88312	624669	52635208
Fluid overload	14.55	9.90	15	89174	27816	53232061
Thyroxine decreased	14.53	9.90	10	89179	556	53259321
Thermal burn	14.51	9.90	29	89160	5204	53254673
Expulsion of medication	14.45	9.90	4	89185	20	53259857
Ultrasound liver abnormal	14.45	9.90	4	89185	20	53259857
Bladder pain	14.39	9.90	16	89173	1697	53258180
Acute hepatic failure	14.35	9.90	5	89184	16715	53243162
Application site infection	14.18	9.90	5	89184	61	53259816
Drug intolerance	14.13	9.90	250	88939	205243	53054634
Withdrawal bleed	14.04	9.90	6	89183	126	53259751
Electrolyte imbalance	14.03	9.90	7	89182	18877	53241000
Encephalopathy	14.03	9.90	25	89164	36783	53223094
Application site pustules	13.70	9.90	4	89185	25	53259852
Trans-sexualism	13.65	9.90	3	89186	4	53259873
Disseminated intravascular coagulation	13.64	9.90	8	89181	19711	53240166
Haematemesis	13.62	9.90	19	89170	30838	53229039
Blood pressure systolic abnormal	13.53	9.90	34	89155	7105	53252772
Emphysema	13.52	9.90	42	89147	9917	53249960
Poor venous access	13.48	9.90	42	89147	9933	53249944
Sinusitis	13.43	9.90	373	88816	168191	53091686
Patient dissatisfaction with treatment	13.43	9.90	5	89184	72	53259805
Periodontitis	13.32	9.90	22	89167	3407	53256470
Psoriasis	13.28	9.90	212	88977	86877	53173000
Oral herpes	13.13	9.90	70	89119	21109	53238768
Mood altered	13.12	9.90	52	89137	13849	53246028
Alanine aminotransferase abnormal	13.07	9.90	23	89166	3750	53256127
Pain in extremity	13.05	9.90	592	88597	284458	52975419
Plasma cell myeloma	13.01	9.90	39	89150	47835	53212042
Blood oestrogen abnormal	12.90	9.90	3	89186	6	53259871
Insulin-like growth factor increased	12.86	9.90	11	89178	846	53259031
Cor pulmonale acute	12.80	9.90	8	89181	377	53259500
Road traffic accident	12.80	9.90	80	89109	25551	53234326
Melaena	12.79	9.90	18	89171	29111	53230766
Tenderness	12.77	9.90	66	89123	19664	53240213
Gastrointestinal disorder	12.74	9.90	93	89096	89911	53169966
Endometrial disorder	12.70	9.90	10	89179	684	53259193
Pulmonary arterial hypertension	12.68	9.90	16	89173	27106	53232771
Therapy non-responder	12.65	9.90	41	89148	49079	53210798
Application site nodule	12.59	9.90	3	89186	7	53259870
Unresponsive to stimuli	12.47	9.90	23	89166	33403	53226474
Pneumonia aspiration	12.45	9.90	24	89165	34277	53225600
Pulmonary oedema	12.39	9.90	47	89142	53676	53206201
Breast hyperplasia	12.38	9.90	7	89182	274	53259603
Intervertebral disc degeneration	12.32	9.90	52	89137	14246	53245631
Drug interaction	12.32	9.90	276	88913	219053	53040824
Device physical property issue	12.27	9.90	15	89174	1760	53258117
Expired product administered	12.22	9.90	29	89160	5847	53254030
Hepatic failure	12.19	9.90	26	89163	35780	53224097
Device defective	12.17	9.90	13	89176	1318	53258559
Hyperglycaemia	12.12	9.90	31	89158	40053	53219824
Head discomfort	12.09	9.90	45	89144	11639	53248238
Sleep disorder	12.07	9.90	151	89038	58719	53201158
Foetal exposure during pregnancy	11.99	9.90	25	89164	34690	53225187
Pulmonary congestion	11.99	9.90	6	89183	16150	53243727
Retinal vein thrombosis	11.98	9.90	8	89181	423	53259454
Ileus	11.96	9.90	5	89184	14950	53244927
Gingival recession	11.94	9.90	13	89176	1347	53258530
Uterine disorder	11.88	9.90	19	89170	2865	53257012
Hypogonadism	11.88	9.90	5	89184	101	53259776
Abnormal uterine bleeding	11.83	9.90	13	89176	1361	53258516
Vitreous floaters	11.83	9.90	28	89161	5637	53254240
Soft tissue swelling	11.79	9.90	11	89178	948	53258929
Application site scab	11.77	9.90	6	89183	190	53259687
Hospitalisation	11.75	9.90	70	89119	70942	53188935
Muscle atrophy	11.71	9.90	30	89159	6344	53253533
Osteoporosis	11.69	9.90	124	89065	46336	53213541
Vaginal prolapse	11.65	9.90	8	89181	443	53259434
Blood pressure abnormal	11.59	9.90	49	89140	13434	53246443
Premature delivery	11.59	9.90	16	89173	26088	53233789
Eosinophilic pleural effusion	11.56	9.90	4	89185	46	53259831
Muscle injury	11.54	9.90	20	89169	29746	53230131
Breast disorder female	11.48	9.90	5	89184	110	53259767
Product residue present	11.48	9.90	23	89166	4133	53255744
Weight increased	11.44	9.90	434	88755	204133	53055744
Benign breast neoplasm	11.41	9.90	12	89177	1195	53258682
Premature menopause	11.37	9.90	10	89179	798	53259079
Underdose	11.27	9.90	68	89121	21454	53238423
Diabetic ketoacidosis	11.27	9.90	10	89179	19905	53239972
Blood corticotrophin increased	11.26	9.90	4	89185	50	53259827
External ear disorder	11.26	9.90	4	89185	50	53259827
Parotid gland enlargement	11.19	9.90	10	89179	815	53259062
Jaundice	11.18	9.90	21	89168	30292	53229585
Rheumatoid nodule	11.17	9.90	3	89186	11861	53248016
Agranulocytosis	11.11	9.90	14	89175	23735	53236142
Breast cancer stage I	11.08	9.90	13	89176	1462	53258415
Hypothermia	11.04	9.90	4	89185	13052	53246825
Product prescribing error	10.96	9.90	71	89118	22960	53236917
Neurotoxicity	10.94	9.90	6	89183	15343	53244534
Hiatus hernia	10.93	9.90	63	89126	19557	53240320
Xanthoma	10.91	9.90	4	89185	55	53259822
Infusion site erythema	10.88	9.90	36	89153	8786	53251091
Stress urinary incontinence	10.83	9.90	16	89173	2251	53257626
Low turnover osteopathy	10.79	9.90	23	89166	4317	53255560
Accidental overdose	10.76	9.90	12	89177	21467	53238410
Red blood cell sedimentation rate increased	10.74	9.90	19	89170	28038	53231839
Product storage error	10.74	9.90	47	89142	13083	53246794
Disturbance in attention	10.73	9.90	96	89093	34287	53225590
Spinal osteoarthritis	10.73	9.90	52	89137	15105	53244772
Blood testosterone decreased	10.72	9.90	4	89185	58	53259819
Carpal tunnel decompression	10.70	9.90	10	89179	864	53259013
Mesenteric haemorrhage	10.59	9.90	4	89185	60	53259817
Inappropriate schedule of product administration	10.57	9.90	180	89009	74698	53185179
Alopecia	10.54	9.90	305	88884	234278	53025599
Musculoskeletal stiffness	10.54	9.90	144	89045	123224	53136653
Blood bilirubin increased	10.52	9.90	28	89161	35702	53224175
Uterine spasm	10.44	9.90	8	89181	526	53259351
Prolapse	10.38	9.90	3	89186	18	53259859
Mammogram abnormal	10.35	9.90	9	89180	707	53259170
Impatience	10.32	9.90	7	89182	380	53259497
Dry mouth	10.25	9.90	148	89041	59402	53200475
Myalgia	10.24	9.90	294	88895	133197	53126680
Mobility decreased	10.23	9.90	80	89109	76191	53183686
Swelling face	10.21	9.90	143	89046	57025	53202852
Stomatitis	10.12	9.90	110	89079	98048	53161829
Seizure	10.07	9.90	154	89035	129355	53130522
Tongue erythema	10.06	9.90	6	89183	260	53259617
Tuberculosis	10.05	9.90	3	89186	11068	53248809
Gingival ulceration	10.04	9.90	10	89179	934	53258943
Premature baby	9.99	9.90	11	89178	19790	53240087
Adnexa uteri pain	9.94	9.90	7	89182	404	53259473
Uterine cancer	9.93	9.90	21	89168	3920	53255957
Labyrinthitis	9.93	9.90	15	89174	2153	53257724
Tooth fracture	9.93	9.90	38	89151	9960	53249917

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
Meningioma	101.48	41.07	19	730	1456	32511321
Off label use	58.26	41.07	51	698	306269	32206508
Foetal exposure during pregnancy	58.06	41.07	25	724	41276	32471501
Prolactin-producing pituitary tumour	46.71	41.07	6	743	34	32512743
Hyperprolactinaemia	42.31	41.07	9	740	1309	32511468

Pharmacologic Action:

Source	Code	Description
ATC	G03CA03	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ESTROGENS Natural and semisynthetic estrogens, plain
ATC	G03AA14	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations
ATC	G03AA17	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, fixed combinations
ATC	G03AB08	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE Progestogens and estrogens, sequential preparations
ATC	G03CA53	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ESTROGENS Natural and semisynthetic estrogens, plain
ATC	H01CC54	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones
FDA CS	M0447348	Estradiol Congeners
FDA MoA	N0000000100	Estrogen Receptor Agonists
MeSH PA	D004967	Estrogens
MeSH PA	D006728	Hormones
FDA EPC	N0000175825	Estrogen
CHEBI has role	CHEBI:50114	oestrogene
CHEBI has role	CHEBI:62872	aldehyde oxidase (EC 1.2.3.1) inhibitors
CHEBI has role	CHEBI:75771	Mus musculus metabolite
CHEBI has role	CHEBI:77746	H. sapiens metabolites
CHEBI has role	CHEBI:83056	Daphnia magna metabolites
CHEBI has role	CHEBI:176497	anti-aging drugs

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Premenstrual dysphoric disorder	indication	596004
Contraception	indication	13197004
Female hypogonadism syndrome	indication	16041008
Atrophic vaginitis	indication	52441000
Urethral atrophy	indication	52620003
Primary ovarian failure	indication	65846009
Acne vulgaris	indication	88616000
Postmenopausal osteoporosis	indication	102447009
Menopausal flushing	indication	198436008
Atrophic vulva	indication	248861000	DOID:14275
Advanced Prostatic Carcinoma	indication
Metastatic Breast Carcinoma	indication
Metastatic Prostate Carcinoma	indication
Amenorrhea	off-label use	14302001	DOID:13938
Polycystic ovaries	off-label use	69878008
Dysmenorrhea	off-label use	266599000
Postcoital contraception	off-label use	268463003
Abnormal uterine bleeding unrelated to menstrual cycle	off-label use	312984006
Menorrhagia	off-label use	386692008
Pre-Menopausal Osteoporosis	off-label use
Heart valve disorder	contraindication	368009	DOID:4079
Hyperlipoproteinemia	contraindication	3744001	DOID:1168
Gynecomastia	contraindication	4754008	DOID:12698
Hypocalcemia	contraindication	5291005
Alcoholism	contraindication	7200002
Weight gain finding	contraindication	8943002
Hypercholesterolemia	contraindication	13644009
Hyperkalemia	contraindication	14140009
Jaundice	contraindication	18165001
Toxic shock syndrome	contraindication	18504008	DOID:14115
Myocardial infarction	contraindication	22298006	DOID:5844
Fibroadenosis of breast	contraindication	23260002	DOID:10352
Diplopia	contraindication	24982008
Retinal hemorrhage	contraindication	28998008
Depressive disorder	contraindication	35489007
Chloasma	contraindication	36209000
Migraine	contraindication	37796009	DOID:6364
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Hypothyroidism	contraindication	40930008	DOID:1459
Body fluid retention	contraindication	43498006
Thrombosis of retinal vein	contraindication	46085004
Humoral hypercalcemia of malignancy	contraindication	47709007
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Dementia	contraindication	52448006
Hepatic porphyria	contraindication	55056006	DOID:3133
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Hyperlipidemia	contraindication	55822004	DOID:1168
Heart disease	contraindication	56265001	DOID:114
Anorexia nervosa	contraindication	56882008	DOID:8689
Benign mammary dysplasia	contraindication	57993004
Acute nephropathy	contraindication	58574008
Obstructive hyperbilirubinemia	contraindication	59848001
Hepatic failure	contraindication	59927004
Cerebrovascular disease	contraindication	62914000	DOID:6713
Thrombophlebitis	contraindication	64156001	DOID:3875
Osteoporosis	contraindication	64859006	DOID:11476
Intermenstrual bleeding - irregular	contraindication	64996003
Hypercalcemia	contraindication	66931009	DOID:12678
Diabetes mellitus	contraindication	73211009	DOID:9351
Sleep apnea	contraindication	73430006	DOID:0050847
Hyperglycemia	contraindication	80394007	DOID:4195
Heart failure	contraindication	84114007	DOID:6000
Epilepsy	contraindication	84757009	DOID:1826
Breast lump	contraindication	89164003
Kidney disease	contraindication	90708001	DOID:557
Malignant neoplasm of liver	contraindication	93870000	DOID:3571
Uterine fibroids	contraindication	95315005	DOID:13223
Neoplasm of prostate	contraindication	126906006	DOID:10283
Neoplasm of female genital organ	contraindication	126907002	DOID:120
Deep venous thrombosis	contraindication	128053003
Seizure disorder	contraindication	128613002
Endometriosis	contraindication	129103003
Bed-ridden	contraindication	160685001
Liver function tests abnormal	contraindication	166603001
Mammography abnormal	contraindication	168750009
Angina pectoris	contraindication	194828000
Asthma	contraindication	195967001	DOID:2841
Cerebrovascular accident	contraindication	230690007
Pulmonary thromboembolism	contraindication	233935004
Thrombophilia	contraindication	234467004	DOID:2452
Disease of liver	contraindication	235856003	DOID:409
Cholestasis of pregnancy	contraindication	235888006
Metabolic syndrome X	contraindication	237602007	DOID:14221
Endometrial carcinoma	contraindication	254878006	DOID:2871
Benign prostatic hyperplasia	contraindication	266569009
Edema	contraindication	267038008
Chorea	contraindication	271700006
Pregnancy, function	contraindication	289908002
Hypertriglyceridemia	contraindication	302870006
Osteopenia	contraindication	312894000
Functional visual loss	contraindication	313165001
Non-Q wave myocardial infarction	contraindication	314207007
Malignant tumor of cervix	contraindication	363354003	DOID:4362
Malignant tumor of ovary	contraindication	363443007	DOID:2394
Thromboembolic disorder	contraindication	371039008
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Cardiovascular event risk	contraindication	395112001
Breastfeeding (mother)	contraindication	413712001
Chronic lung disease	contraindication	413839001
Disorder of coronary artery	contraindication	414024009
Obesity	contraindication	414916001	DOID:9970
Estrogen receptor positive tumor	contraindication	416053008
Porphyria	contraindication	418470004
Resistance to activated protein C due to Factor V Leiden	contraindication	421527008
Optic disc edema	contraindication	423341008	DOID:146
Family history of malignant neoplasm of breast	contraindication	429740004
Hypertensive urgency	contraindication	443482000
Carcinoma of female breast	contraindication	447782002
Smokes tobacco daily	contraindication	449868002
Diabetes with Vascular Disease Complication	contraindication
Breast Carcinoma in Males	contraindication
Acute Thromboembolic Stroke	contraindication
Major Surgery with Prolonged Post-Operative Immobilization	contraindication
Nonspecific Abnormal Papanicolaou Smear of Cervix	contraindication
Worsening Headache Disorder	contraindication
Benign Hepatic Cell Adenoma	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.13	acidic

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
10MCG	VAGIFEM	NOVO NORDISK INC	N020908	Nov. 25, 2009	RX	TABLET	VAGINAL	7018992	Sept. 17, 2022	TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	9346822	Feb. 17, 2024	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN
0.025MG/24HR	MINIVELLE	NOVEN	N203752	Sept. 23, 2014	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.0375MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.05MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.075MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.1MG/24HR	MINIVELLE	NOVEN	N203752	Oct. 29, 2012	RX	FILM, EXTENDED RELEASE	TRANSDERMAL	9730900	July 10, 2028	A METHOD FOR ADMINISTERING ESTRADIOL COMPRISING A MONOLITHIC TRANSDERMAL DRUG DELIVERY SYSTEM CONSISTING OF (I) A BACKING LAYER AND (II) A SINGLE ADHESIVE POLYMER MATRIX LAYER AS CLAIMED IN US PATENT NO. 9730900
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10537581	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10835487	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11241445	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	11246875	Nov. 21, 2032	TREATMENT OF DYSPAREUNIA
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	10206932	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	10675288	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	11033626	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	8846648	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	8846649	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	8933059	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	9114145	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	9114146	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.5MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Dec. 28, 2021	RX	CAPSULE	ORAL	9301920	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10206932	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10675288	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	10806740	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	11033626	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	11103513	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	8846648	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	8846649	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9006222	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9114145	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9114146	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
1MG;100MG	BIJUVA	THERAPEUTICSMD INC	N210132	Oct. 28, 2018	RX	CAPSULE	ORAL	9301920	Nov. 21, 2032	TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10471072	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10568891	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10668082	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10888516	June 18, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.004MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10258630	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	10398708	Dec. 20, 2033	TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
0.01MG	IMVEXXY	THERAPEUTICSMD INC	N208564	May 29, 2018	RX	INSERT	VAGINAL	9180091	Dec. 20, 2033	TREATMENT OF DYSPAREUNIA
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE INC	N213388	May 29, 2020	RX	CAPSULE	ORAL	10881659	March 14, 2034	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE INC	N213388	May 29, 2020	RX	CAPSULE	ORAL	11045470	March 14, 2034	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS)
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	11033551	Sept. 29, 2037	MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE INC	N213388	May 29, 2020	RX	CAPSULE	ORAL	May 29, 2023	NEW PRODUCT
EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE	ORIAHNN (COPACKAGED)	ABBVIE INC	N213388	May 29, 2020	RX	CAPSULE	ORAL	July 23, 2023	NEW CHEMICAL ENTITY
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	May 26, 2024	NEW PRODUCT
1MG;0.5MG;40MG	MYFEMBREE	MYOVANT SCIENCES	N214846	May 26, 2021	RX	TABLET	ORAL	Dec. 18, 2025	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Estrogen receptor	Nuclear hormone receptor	P03372	ESR1_HUMAN	AGONIST	EC50	10.30	WOMBAT-PK	CHEMBL
Aldehyde oxidase	Enzyme	Q06278	AOXA_HUMAN		IC50	6.54	WOMBAT-PK
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		Ki	4.73	DRUG MATRIX
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	4.93	DRUG MATRIX
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN		IC50	7.72	CHEMBL
Calcium-activated potassium channel subunit alpha-1	Ion channel	Q12791	KCMA1_HUMAN	ACTIVATOR	EC50	5.60	IUPHAR
Estrogen receptor beta	Nuclear hormone receptor	Q92731	ESR2_HUMAN		EC50	9.70	WOMBAT-PK
G-protein coupled estrogen receptor 1	GPCR	Q99527	GPER1_HUMAN		EC50	9.52	WOMBAT-PK
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	5	CHEMBL
Steryl-sulfatase	Enzyme	P08842	STS_HUMAN		IC50	4.08	CHEMBL
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	8.83	CHEMBL
Steroid hormone receptor ERR1	Nuclear hormone receptor	P11474	ERR1_HUMAN		IC50	8.44	CHEMBL
Steroid hormone receptor ERR2	Nuclear hormone receptor	O95718	ERR2_HUMAN		IC50	8.49	CHEMBL
Cytochrome P450 1B1	Enzyme	Q16678	CP1B1_HUMAN		Ki	5.72	CHEMBL
Sodium-dependent serotonin transporter	Transporter	P31645	SC6A4_HUMAN		Ki	5.24	DRUG MATRIX
Androgen receptor	Transcription factor		ANDR_RAT		IC50	6.39	CHEMBL
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	4.95	DRUG MATRIX
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	5.37	DRUG MATRIX
Estrogen receptor	Transcription factor		ESR1_RAT		IC50	8.72	CHEMBL
Estrogen receptor beta	Transcription factor		ESR2_RAT		IC50	8.77	CHEMBL
Estrogen receptor beta	Transcription factor		ESR2_MOUSE		IC50	8.64	CHEMBL
Estrogen receptor	Transcription factor		ESR1_MOUSE		IC50	8.66	CHEMBL
Estrogen receptor	Transcription factor		ESR1_RAT ESR2_RAT		IC50	9.45	CHEMBL

External reference:

ID	Source
4021205	VUID
N0000148651	NUI
D00105	KEGG_DRUG
35380-71-3	SECONDARY_CAS_RN
4017609	VANDF
4021205	VANDF
C0014912	UMLSCUI
CHEBI:16469	CHEBI
EST	PDB_CHEM_ID
CHEMBL135	ChEMBL_ID
DB00783	DRUGBANK_ID
D004958	MESH_DESCRIPTOR_UI
5757	PUBCHEM_CID
406	INN_ID
4TI98Z838E	UNII
236859	RXNORM
160774	MMSL
18201	MMSL
36188	MMSL
4684	MMSL
6157	MMSL
73244	MMSL
8602	MMSL
d00537	MMSL
001265	NDDF
007018	NDDF
116070003	SNOMEDCT_US
126172005	SNOMEDCT_US
12839006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Estring	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2150	RING	2 mg	VAGINAL	NDA	27 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5885	PATCH	0.03 mg	TRANSDERMAL	NDA	35 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5886	PATCH	0.05 mg	TRANSDERMAL	NDA	35 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5887	PATCH	0.08 mg	TRANSDERMAL	NDA	35 sections
Alora	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5888	PATCH	0.10 mg	TRANSDERMAL	NDA	35 sections
ELESTRIN	HUMAN PRESCRIPTION DRUG LABEL	1	0037-4801	GEL, METERED	0.52 mg	TOPICAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0343	PATCH, EXTENDED RELEASE	0.04 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0344	PATCH, EXTENDED RELEASE	0.05 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0345	PATCH, EXTENDED RELEASE	0.08 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0346	PATCH, EXTENDED RELEASE	0.10 mg	TRANSDERMAL	NDA	33 sections
Vivelle-Dot	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0365	PATCH, EXTENDED RELEASE	0.03 mg	TRANSDERMAL	NDA	33 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3223	INSERT	10 ug	VAGINAL	ANDA	29 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3541	CREAM	0.10 mg	VAGINAL	ANDA	25 sections
Mimvey	HUMAN PRESCRIPTION DRUG LABEL	2	0093-5455	TABLET, FILM COATED	1 mg	ORAL	ANDA	30 sections
Estradiol Vaginal	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1518	CREAM	0.10 mg	VAGINAL	ANDA	23 sections
Vagifem	HUMAN PRESCRIPTION DRUG LABEL	1	0169-5176	INSERT	10 ug	VAGINAL	NDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3349	PATCH	0.03 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3350	PATCH	0.05 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3351	PATCH	0.08 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3352	PATCH	0.10 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3360	PATCH	0.04 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-3361	PATCH	0.06 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4619	PATCH	0.03 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4620	PATCH	0.04 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4621	PATCH	0.05 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4622	PATCH	0.08 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4623	PATCH	0.10 mg	TRANSDERMAL	ANDA	30 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4640	PATCH	0.10 mg	TRANSDERMAL	ANDA	31 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4641	PATCH	0.08 mg	TRANSDERMAL	ANDA	31 sections
Estradiol	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4642	PATCH	0.05 mg	TRANSDERMAL	ANDA	31 sections