All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

loteprednol etabonate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	1611	82034-46-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: loteprednol etabonate lenoxin lotemax	An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions. Molecular weight: 466.96 Formula: C24H31ClO7 CLOGP: 3.34 LIPINSKI: 0 HAC: 7 HDO: 1 TPSA: 99.13 ALOGS: -4.83 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,TTK,ZAP70	40
kinase-selectivity-class	AXL,GRK2,MAP2K6,STK33	4
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
March 9, 1998	FDA	BAUSCH AND LOMB

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
Eye irritation	284	19.70	93	4335	33885	90590134
Eye pain	215.51	19.70	81	4347	44087	90579932
Ocular hyperaemia	154.01	19.70	59	4369	33739	90590280
Intraocular pressure increased	136.31	19.70	37	4391	7056	90616963
Vision blurred	100.15	19.70	64	4364	110229	90513790
Eye pruritus	75.56	19.70	34	4394	28993	90595026
Foreign body sensation in eyes	71.82	19.70	19	4409	3281	90620738
Dry eye	71.59	19.70	41	4387	57890	90566129
Lacrimation increased	71.39	19.70	32	4396	27030	90596989
Corneal oedema	66.51	19.70	16	4412	1885	90622134
Cataract	60.86	19.70	40	4388	72052	90551967
Punctate keratitis	51.15	19.70	11	4417	785	90623234
Photophobia	49.33	19.70	23	4405	21246	90602773
Visual acuity reduced	47.22	19.70	23	4405	23387	90600632
Ocular discomfort	43.47	19.70	15	4413	6355	90617664
Dacryostenosis acquired	40.24	19.70	9	4419	770	90623249
Endophthalmitis	39.76	19.70	13	4415	4672	90619347
Eye swelling	34.16	19.70	20	4408	29366	90594653
Eye inflammation	33.20	19.70	13	4415	7838	90616181
Ulcerative keratitis	31.00	19.70	10	4418	3443	90620576
Visual impairment	30.66	19.70	35	4393	132330	90491689
Product dose omission issue	29.72	19.70	52	4376	291635	90332384
Instillation site pain	28.31	19.70	7	4421	923	90623096
Corneal defect	28.07	19.70	4	4424	23	90623996
Corneal scar	27.60	19.70	5	4423	146	90623873
Corneal disorder	27.18	19.70	8	4420	2034	90621985
Cystoid macular oedema	26.96	19.70	8	4420	2092	90621927
Conjunctivitis allergic	25.82	19.70	7	4421	1325	90622694
Diffuse lamellar keratitis	24.70	19.70	3	4425	3	90624016
Uveitis	24.42	19.70	13	4415	15890	90608129
Glaucoma	23.78	19.70	14	4414	20741	90603278
Giant papillary conjunctivitis	23.49	19.70	3	4425	6	90624013
Hypopyon	23.45	19.70	6	4422	908	90623111
Abnormal sensation in eye	23.11	19.70	7	4421	1964	90622055
Corneal infection	22.72	19.70	4	4424	99	90623920
Undifferentiated connective tissue disease	21.33	19.70	4	4424	142	90623877
Corneal thickening	20.30	19.70	3	4425	23	90623996

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
Eye irritation	107.62	26.27	32	1539	11286	42608478
Eye pain	106.74	26.27	35	1536	16995	42602769
Intraocular pressure increased	87.23	26.27	24	1547	6409	42613355
Ulcerative keratitis	53.81	26.27	13	1558	2075	42617689
Vision blurred	48.38	26.27	28	1543	53671	42566093
Corneal oedema	46.97	26.27	11	1560	1537	42618227
Corneal perforation	37.77	26.27	7	1564	311	42619453
Dacryostenosis acquired	37.69	26.27	7	1564	315	42619449
Visual impairment	34.92	26.27	21	1550	43092	42576672
Ocular hyperaemia	34.23	26.27	15	1556	15948	42603816
Diffuse lamellar keratitis	34.07	26.27	4	1567	4	42619760
Corneal deposits	33.14	26.27	6	1565	234	42619530
Photophobia	32.64	26.27	12	1559	8107	42611657
Corneal dystrophy	31.08	26.27	5	1566	95	42619669
Corneal disorder	29.38	26.27	7	1564	1052	42618712
Corneal striae	29.20	26.27	4	1567	23	42619741
Corneal infiltrates	28.22	26.27	5	1566	172	42619592
Corneal opacity	27.04	26.27	6	1565	659	42619105
Corneal graft rejection	26.58	26.27	4	1567	48	42619716

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
Eye irritation	258.31	19.10	84	4758	33368	110551089
Eye pain	228.76	19.10	85	4757	50014	110534443
Intraocular pressure increased	146.80	19.10	42	4800	10834	110573623
Ocular hyperaemia	127.24	19.10	52	4790	39234	110545223
Vision blurred	107.24	19.10	68	4774	128954	110455503
Corneal oedema	94.71	19.10	23	4819	3150	110581307
Dry eye	71.63	19.10	39	4803	55754	110528703
Ulcerative keratitis	71.50	19.10	20	4822	4746	110579711
Eye pruritus	68.88	19.10	32	4810	32743	110551714
Diffuse lamellar keratitis	66.75	19.10	8	4834	8	110584449
Dacryostenosis acquired	66.00	19.10	13	4829	671	110583786
Foreign body sensation in eyes	54.65	19.10	15	4827	3319	110581138
Lacrimation increased	52.23	19.10	26	4816	30924	110553533
Photophobia	50.56	19.10	24	4818	25747	110558710
Corneal deposits	49.52	19.10	10	4832	586	110583871
Corneal striae	47.24	19.10	7	4835	62	110584395
Punctate keratitis	42.52	19.10	10	4832	1194	110583263
Corneal infiltrates	41.73	19.10	8	4834	358	110584099
Endophthalmitis	41.39	19.10	15	4827	8172	110576285
Visual impairment	40.75	19.10	39	4803	134389	110450068
Visual acuity reduced	39.92	19.10	22	4820	32151	110552306
Corneal disorder	39.42	19.10	11	4831	2586	110581871
Corneal dystrophy	37.68	19.10	7	4835	264	110584193
Corneal scar	36.05	19.10	7	4835	335	110584122
Eye swelling	34.01	19.10	20	4822	33028	110551429
Cataract	33.93	19.10	28	4814	79457	110505000
Ocular discomfort	33.53	19.10	13	4829	8520	110575937
Corneal opacity	31.93	19.10	8	4834	1243	110583214
Hypopyon	30.82	19.10	8	4834	1432	110583025
Cystoid macular oedema	29.80	19.10	9	4833	2791	110581666
Corneal perforation	28.88	19.10	7	4835	949	110583508
Giant papillary conjunctivitis	28.82	19.10	4	4838	21	110584436
Corneal thickening	27.96	19.10	4	4838	27	110584430
Abnormal sensation in eye	27.51	19.10	8	4834	2178	110582279
Visual acuity tests abnormal	27.30	19.10	5	4837	174	110584283
Eye inflammation	25.83	19.10	11	4831	9160	110575297
Glaucoma	24.15	19.10	14	4828	22503	110561954
Eye discharge	23.01	19.10	10	4832	8744	110575713
Corneal flap complication	22.71	19.10	3	4839	10	110584447
Corneal infection	22.61	19.10	4	4838	114	110584343
Dermatitis atopic	22.52	19.10	14	4828	25527	110558930
Corneal graft rejection	22.08	19.10	4	4838	131	110584326
Bladder cyst	21.88	19.10	4	4838	138	110584319
Corneal endothelial cell loss	21.57	19.10	3	4839	16	110584441
Toxic anterior segment syndrome	20	19.10	7	4835	3447	110581010
Undifferentiated connective tissue disease	19.75	19.10	4	4838	238	110584219
Product residue present	19.10	19.10	7	4835	3934	110580523

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	S01BA14	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain
ATC	S01CA12	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION Corticosteroids and antiinfectives in combination
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
MeSH PA	D018926	Anti-Allergic Agents
CHEBI has role	CHEBI:35472	anti-inflammatory drug
CHEBI has role	CHEBI:66981	ophthalmology drug
CHEBI has role	CHEBI:67079	anti-inflammatory agent
CHEBI has role	CHEBI:35679	antilipemic drug

Related Drugs by ATC class:

S01BA Corticosteroids, plain 15 drugs

alclometasone dipropionatebetamethasoneclobetasol propionateclobetasone butyratedesonidedexamethasonedifluprednatefluocinolone acetonidefluorometholoneformocortalhydrocortisonemedrysone show all 15 →

S01CA Corticosteroids and antiinfectives in combination 11 drugs

betamethasonechloroprednisoneclobetasone butyratedexamethasonefludrocortisone acetatefluocinolone acetonidefluocortolonefluorometholonehydrocortisonemethylprednisoloneprednisolone

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

Disease	Relation	SNOMED_ID	DOID
Herpes zoster keratoconjunctivitis	indication	42448002
Punctate keratitis	indication	42513006	DOID:12197
Iritis	indication	65074000	DOID:1406
Perforation of cornea	indication	74895004
Iridocyclitis	indication	77971008
Corneal abrasion	indication	85848002
Uveitis	indication	128473001	DOID:13141
Ocular rosacea	indication	200933006
Herpes zoster keratitis	indication	397573005
Rosacea	indication	398909004	DOID:8881
Anterior uveitis	indication	410692006	DOID:1407
Allergic conjunctivitis	indication	473460002	DOID:11204
Post-Op Ocular Inflammation	indication
Ocular hypertension	contraindication	4210003	DOID:9282
Glaucoma	contraindication	23986001	DOID:1686
Herpes simplex dendritic keratitis	contraindication	29943008
Fungal infection of eye	contraindication	31194008
Tuberculosis of eye	contraindication	49107007
Herpes zoster ophthalmicus	contraindication	87513003
Viral eye infection	contraindication	312132001
Vaccinia keratitis	contraindication	397552005

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.33	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
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	10058511	May 3, 2033	A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	10864219	May 3, 2033	A METHOD FOR TREATING OCULAR INFLAMMATION
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	11219597	May 3, 2033	A METHOD OF REDUCING POST-SURGICAL PAIN FOLLOWING OCULAR SURGERY
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	11219597	May 3, 2033	A METHOD OF TREATING POSTOPERATIVE INFLAMMATION FOLLOWING OCULAR SURGERY
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	12115246	May 3, 2033	A METHOD FOR THE TREATMENT OF POST-OPERATIVE INFLAMMATION FOLLOWING OCULAR SURGERY
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	9056057	May 3, 2033	A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	9532955	May 3, 2033	A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	9737491	May 3, 2033	A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
1%	INVELTYS	ALCON LABS INC	N210565	Aug. 22, 2018	RX	SUSPENSION/DROPS	OPHTHALMIC	9827191	May 3, 2033	A METHOD FOR TREATING INFLAMMATION AND/OR OTHER DISORDERS IN AN EYE OF A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10058511	May 3, 2033	A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10857096	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10940108	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10945948	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	10993908	May 3, 2033	ADMINISTRATION TO THE EYE OF A PATIENT FOR TREATMENT OF DRY EYE CONDITION
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	11219596	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	11596599	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	12115246	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	9056057	May 3, 2033	A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	9532955	May 3, 2033	A METHOD FOR DELIVERING A COMPOSITION TO A MUCUS MEMBRANE
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	9737491	May 3, 2033	A METHOD FOR DELIVERING A PHARMACEUTICAL AGENT ACROSS A MUCOSAL BARRIER
0.25%	EYSUVIS	ALCON LABS INC	N210933	Oct. 26, 2020	RX	SUSPENSION/DROPS	OPHTHALMIC	9827191	May 3, 2033	A METHOD FOR TREATING DRY EYE IN A PATIENT
0.38%	LOTEMAX SM	BAUSCH AND LOMB INC	N208219	Feb. 22, 2019	RX	GEL	OPHTHALMIC	11534395	Jan. 26, 2036	TREATMENT OF POST-OPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY
0.38%	LOTEMAX SM	BAUSCH AND LOMB INC	N208219	Feb. 22, 2019	RX	GEL	OPHTHALMIC	12589069	Jan. 26, 2036	TREATMENT OF POST-OPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY
0.38%	LOTEMAX SM	BAUSCH AND LOMB INC	N208219	Feb. 22, 2019	RX	GEL	OPHTHALMIC	10596107	Dec. 23, 2036	TREATMENT OF POST-OPERATIVE INFLAMMATION AND PAIN FOLLOWING OCULAR SURGERY

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.5%;0.3%	LOTEPREDNOL ETABONATE AND TOBRAMYCIN	ALEMBIC	A217597	Dec. 10, 2025	RX	SUSPENSION/DROPS	OPHTHALMIC	July 14, 2026	COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST				DRUGBANK	CHEMBL

External reference:

ID	Source
4021086	VUID
N0000179334	NUI
D01689	KEGG_DRUG
4021086	VANDF
4024100	VANDF
C0126177	UMLSCUI
CHEMBL1200865	ChEMBL_ID
D000069559	MESH_DESCRIPTOR_UI
DB14596	DRUGBANK_ID
7085	IUPHAR_LIGAND_ID
YEH1EZ96K6	UNII
444025	PUBCHEM_CID
DB00873	DRUGBANK_ID
218087	RXNORM
11633	MMSL
315769	MMSL
4997	MMSL
007442	NDDF
007443	NDDF
108857005	SNOMEDCT_US
387047007	SNOMEDCT_US
419711001	SNOMEDCT_US
CHEMBL1201389	ChEMBL_ID
129260-79-3	SECONDARY_CAS_RN
9865442	PUBCHEM_CID
6654	INN_ID
Z8CBU6KR16	UNII
CHEBI:50848	CHEBI
Z8CBU6KR16	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Inveltys	HUMAN PRESCRIPTION DRUG LABEL	1	0065-9307	SUSPENSION	10 mg	OPHTHALMIC	NDA	24 sections
LOTEPREDNOL ETABONATE	HUMAN PRESCRIPTION DRUG LABEL	1	0574-4080	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	ANDA	18 sections
LOTEPREDNOL ETABONATE	HUMAN PRESCRIPTION DRUG LABEL	1	0574-4135	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	17 sections
ALREX	HUMAN PRESCRIPTION DRUG LABEL	1	16590-007	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	20 sections
LOTEMAX	HUMAN PRESCRIPTION DRUG LABEL	1	24208-299	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	NDA	17 sections
Alrex	HUMAN PRESCRIPTION DRUG LABEL	1	24208-353	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	20 sections
Zylet	HUMAN PRESCRIPTION DRUG LABEL	2	24208-358	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	NDA	21 sections
Lotemax	HUMAN PRESCRIPTION DRUG LABEL	1	24208-443	OINTMENT	5 mg	OPHTHALMIC	NDA	22 sections
LOTEMAX	HUMAN PRESCRIPTION DRUG LABEL	1	24208-503	GEL	5 mg	OPHTHALMIC	NDA	22 sections
Lotemax SM	HUMAN PRESCRIPTION DRUG LABEL	1	24208-507	GEL	3.80 mg	OPHTHALMIC	NDA	22 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	24208-508	GEL	5 mg	OPHTHALMIC	NDA authorized generic	22 sections
Loteprednol etabonate and Tobramycin	Human Prescription Drug Label	2	46708-801	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	21 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	50383-265	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	17 sections
ALREX	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4277	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	20 sections
LOTEMAX	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4278	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	NDA	18 sections
LOTEPREDNOL ETABONATE	HUMAN PRESCRIPTION DRUG LABEL	1	60219-1362	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	16 sections
loteprednol etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	60219-1366	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	ANDA	18 sections
loteprednol etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	60219-1367	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	ANDA	18 sections
Loteprednol etabonate and Tobramycin	Human Prescription Drug Label	2	62332-801	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	21 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	62756-232	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	16 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	70244-034	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	17 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	70244-035	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	ANDA	17 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	70244-036	GEL	5 mg	OPHTHALMIC	ANDA	23 sections
loteprednol etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	70748-300	SUSPENSION	5 mg	OPHTHALMIC	ANDA	14 sections
Inveltys	HUMAN PRESCRIPTION DRUG LABEL	1	71571-121	SUSPENSION	10 mg	TOPICAL	NDA	24 sections
Eysuvis	HUMAN PRESCRIPTION DRUG LABEL	1	71571-333	SUSPENSION/ DROPS	2.50 mg	OPHTHALMIC	NDA	23 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	72485-630	GEL	5 mg	OPHTHALMIC	ANDA	23 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	72485-653	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	ANDA	17 sections
Loteprednol Etabonate	HUMAN PRESCRIPTION DRUG LABEL	1	72485-665	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	16 sections
LOTEPREDNOL ETABONATE	HUMAN PRESCRIPTION DRUG LABEL	1	72603-324	SUSPENSION/ DROPS	5 mg	OPHTHALMIC	ANDA	17 sections