loteprednol etabonate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| prednisone and prednisolone derivatives | 1611 | 82034-46-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions.
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 |
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 | 244.75 | 20.46 | 76 | 3237 | 21895 | 63463814 |
| Eye pain | 132.86 | 20.46 | 54 | 3259 | 33800 | 63451909 |
| Ocular hyperaemia | 115.68 | 20.46 | 45 | 3268 | 25099 | 63460610 |
| Intraocular pressure increased | 111.51 | 20.46 | 31 | 3282 | 6047 | 63479662 |
| Vision blurred | 77.07 | 20.46 | 52 | 3261 | 91872 | 63393837 |
| Corneal oedema | 69.31 | 20.46 | 16 | 3297 | 1477 | 63484232 |
| Foreign body sensation in eyes | 62.90 | 20.46 | 16 | 3297 | 2218 | 63483491 |
| Lacrimation increased | 57.96 | 20.46 | 26 | 3287 | 20605 | 63465104 |
| Cataract | 56.87 | 20.46 | 36 | 3277 | 57017 | 63428692 |
| Eye pruritus | 50.76 | 20.46 | 23 | 3290 | 18648 | 63467061 |
| Photophobia | 48.82 | 20.46 | 22 | 3291 | 17613 | 63468096 |
| Dry eye | 43.83 | 20.46 | 27 | 3286 | 40734 | 63444975 |
| Endophthalmitis | 42.32 | 20.46 | 13 | 3300 | 3579 | 63482130 |
| Dacryostenosis acquired | 41.86 | 20.46 | 9 | 3304 | 600 | 63485109 |
| Punctate keratitis | 41.69 | 20.46 | 9 | 3304 | 612 | 63485097 |
| Visual acuity reduced | 41.40 | 20.46 | 21 | 3292 | 21805 | 63463904 |
| Eye inflammation | 32.90 | 20.46 | 12 | 3301 | 5587 | 63480122 |
| Corneal defect | 29.01 | 20.46 | 4 | 3309 | 16 | 63485693 |
| Corneal scar | 28.72 | 20.46 | 5 | 3308 | 108 | 63485601 |
| Ulcerative keratitis | 28.53 | 20.46 | 9 | 3304 | 2701 | 63483008 |
| Visual impairment | 28.27 | 20.46 | 28 | 3285 | 84418 | 63401291 |
| Instillation site pain | 28.05 | 20.46 | 7 | 3306 | 897 | 63484812 |
| Corneal disorder | 27.60 | 20.46 | 8 | 3305 | 1806 | 63483903 |
| Ocular discomfort | 24.60 | 20.46 | 9 | 3304 | 4224 | 63481485 |
| Diffuse lamellar keratitis | 24.51 | 20.46 | 3 | 3310 | 3 | 63485706 |
| Hypopyon | 24.38 | 20.46 | 6 | 3307 | 726 | 63484983 |
| Cystoid macular oedema | 24.20 | 20.46 | 7 | 3306 | 1568 | 63484141 |
| Eye swelling | 23.57 | 20.46 | 15 | 3298 | 23903 | 63461806 |
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 | 93.80 | 29.53 | 25 | 994 | 7536 | 34948376 |
| Eye pain | 83.75 | 29.53 | 26 | 993 | 13436 | 34942476 |
| Intraocular pressure increased | 62.95 | 29.53 | 17 | 1002 | 5366 | 34950546 |
| Corneal oedema | 51.05 | 29.53 | 11 | 1008 | 1340 | 34954572 |
| Vision blurred | 41.12 | 29.53 | 22 | 997 | 45941 | 34909971 |
| Ulcerative keratitis | 37.76 | 29.53 | 9 | 1010 | 1720 | 34954192 |
| Diffuse lamellar keratitis | 35.01 | 29.53 | 4 | 1015 | 4 | 34955908 |
| Corneal striae | 33.39 | 29.53 | 4 | 1015 | 8 | 34955904 |
| Corneal disorder | 31.90 | 29.53 | 7 | 1012 | 927 | 34954985 |
| Corneal dystrophy | 31.73 | 29.53 | 5 | 1014 | 106 | 34955806 |
| Corneal infiltrates | 29.87 | 29.53 | 5 | 1014 | 156 | 34955756 |
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 | 216.01 | 20.89 | 65 | 3335 | 20616 | 79720372 |
| Eye pain | 155.85 | 20.89 | 59 | 3341 | 37519 | 79703469 |
| Intraocular pressure increased | 109.37 | 20.89 | 32 | 3368 | 9173 | 79731815 |
| Corneal oedema | 99.72 | 20.89 | 23 | 3377 | 2597 | 79738391 |
| Vision blurred | 84.88 | 20.89 | 54 | 3346 | 105844 | 79635144 |
| Ocular hyperaemia | 80.99 | 20.89 | 34 | 3366 | 28172 | 79712816 |
| Diffuse lamellar keratitis | 66.97 | 20.89 | 8 | 3392 | 8 | 79740980 |
| Dacryostenosis acquired | 62.86 | 20.89 | 12 | 3388 | 540 | 79740448 |
| Ulcerative keratitis | 58.15 | 20.89 | 16 | 3384 | 3673 | 79737315 |
| Corneal striae | 55.12 | 20.89 | 7 | 3393 | 16 | 79740972 |
| Foreign body sensation in eyes | 51.48 | 20.89 | 13 | 3387 | 2144 | 79738844 |
| Photophobia | 46.67 | 20.89 | 21 | 3379 | 20507 | 79720481 |
| Eye pruritus | 46.63 | 20.89 | 21 | 3379 | 20549 | 79720439 |
| Corneal deposits | 45.48 | 20.89 | 9 | 3391 | 489 | 79740499 |
| Endophthalmitis | 45.34 | 20.89 | 15 | 3385 | 6413 | 79734575 |
| Punctate keratitis | 44.77 | 20.89 | 10 | 3390 | 976 | 79740012 |
| Corneal infiltrates | 43.27 | 20.89 | 8 | 3392 | 302 | 79740686 |
| Dry eye | 43.03 | 20.89 | 24 | 3376 | 36907 | 79704081 |
| Corneal disorder | 41.08 | 20.89 | 11 | 3389 | 2280 | 79738708 |
| Corneal dystrophy | 37.92 | 20.89 | 7 | 3393 | 262 | 79740726 |
| Corneal scar | 36.97 | 20.89 | 7 | 3393 | 301 | 79740687 |
| Cataract | 36.12 | 20.89 | 26 | 3374 | 62094 | 79678894 |
| Lacrimation increased | 35.79 | 20.89 | 18 | 3382 | 22459 | 79718529 |
| Visual acuity reduced | 33.91 | 20.89 | 19 | 3381 | 29450 | 79711538 |
| Corneal opacity | 33.77 | 20.89 | 8 | 3392 | 1012 | 79739976 |
| Visual impairment | 33.00 | 20.89 | 29 | 3371 | 92102 | 79648886 |
| Hypopyon | 32.87 | 20.89 | 8 | 3392 | 1134 | 79739854 |
| Giant papillary conjunctivitis | 32.21 | 20.89 | 4 | 3396 | 7 | 79740981 |
| Visual acuity tests abnormal | 29.35 | 20.89 | 5 | 3395 | 117 | 79740871 |
| Corneal thickening | 29.09 | 20.89 | 4 | 3396 | 20 | 79740968 |
| Cystoid macular oedema | 28.51 | 20.89 | 8 | 3392 | 1972 | 79739016 |
| Eye inflammation | 26.28 | 20.89 | 10 | 3390 | 6403 | 79734585 |
| Eye infection | 23.35 | 20.89 | 11 | 3389 | 11909 | 79729079 |
| Incorrect product administration duration | 23.26 | 20.89 | 11 | 3389 | 12011 | 79728977 |
| Bladder cyst | 23.08 | 20.89 | 4 | 3396 | 104 | 79740884 |
| Corneal endothelial cell loss | 23.03 | 20.89 | 3 | 3397 | 9 | 79740979 |
| Corneal flap complication | 22.79 | 20.89 | 3 | 3397 | 10 | 79740978 |
| Eye swelling | 22.41 | 20.89 | 14 | 3386 | 26454 | 79714534 |
| Toxic anterior segment syndrome | 21.72 | 20.89 | 7 | 3393 | 2757 | 79738231 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | S01BA14 | SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Corticosteroids, plain |
| FDA MoA | N0000175450 | Corticosteroid Hormone Receptor Agonists |
| FDA EPC | N0000175576 | Corticosteroid |
| MeSH PA | D018926 | Anti-Allergic Agents |
| CHEBI has role | CHEBI:35679 | antilipemic drugs |
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 | 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 | 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 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 0.25% | EYSUVIS | ALCON LABS INC | N210933 | Oct. 26, 2020 | RX | SUSPENSION/DROPS | OPHTHALMIC | Oct. 26, 2023 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Glucocorticoid receptor | Nuclear hormone receptor | AGONIST | DRUGBANK | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021086 | VUID |
| N0000179334 | NUI |
| D01689 | KEGG_DRUG |
| 4021086 | VANDF |
| 4024100 | VANDF |
| C0126177 | UMLSCUI |
| CHEBI:50848 | CHEBI |
| CHEMBL1200865 | ChEMBL_ID |
| D000069559 | MESH_DESCRIPTOR_UI |
| DB14596 | DRUGBANK_ID |
| 7085 | IUPHAR_LIGAND_ID |
| YEH1EZ96K6 | UNII |
| 444025 | PUBCHEM_CID |
| DB00873 | DRUGBANK_ID |
| 202988 | RXNORM |
| 11633 | MMSL |
| 1692 | MMSL |
| 315769 | MMSL |
| 4997 | MMSL |
| 007442 | NDDF |
| 007443 | NDDF |
| 108857005 | SNOMEDCT_US |
| 387047007 | SNOMEDCT_US |
| 419711001 | SNOMEDCT_US |
| CHEMBL1201389 | ChEMBL_ID |
| 6654 | INN_ID |
| 129260-79-3 | SECONDARY_CAS_RN |
| 9865442 | PUBCHEM_CID |
| Z8CBU6KR16 | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ALREX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-007 | SUSPENSION/ DROPS | 2 mg | OPHTHALMIC | NDA | 20 sections |
| Loteprednol Etabonate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-830 | GEL | 5 mg | OPHTHALMIC | ANDA | 23 sections |
| Loteprednol Etabonate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17478-830 | GEL | 5 mg | OPHTHALMIC | ANDA | 23 sections |
| LOTEMAX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-299 | SUSPENSION/ DROPS | 5 mg | OPHTHALMIC | NDA | 19 sections |
| LOTEMAX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-299 | SUSPENSION/ DROPS | 5 mg | OPHTHALMIC | NDA | 19 sections |
| ALREX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-353 | SUSPENSION/ DROPS | 2 mg | OPHTHALMIC | NDA | 20 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 |
| Zylet | HUMAN PRESCRIPTION DRUG LABEL | 2 | 24208-358 | SUSPENSION/ DROPS | 5 mg | OPHTHALMIC | NDA | 21 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 | 24208-443 | OINTMENT | 5 mg | OPHTHALMIC | NDA | 22 sections |
| LOTEMAX | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-503 | GEL | 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 |
| 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 | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50383-265 | SUSPENSION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 17 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 | 62756-232 | SUSPENSION/ DROPS | 5 mg | OPHTHALMIC | ANDA | 16 sections |
| Loteprednol Etabonate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68682-299 | SUSPENSION/ DROPS | 5 mg | OPHTHALMIC | NDA authorized generic | 18 sections |
| Inveltys | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71571-121 | SUSPENSION | 10 mg | TOPICAL | NDA | 24 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 |
| Eysuvis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71571-333 | SUSPENSION/ DROPS | 2.50 mg | OPHTHALMIC | NDA | 23 sections |
| Loteprednol Etabonate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82260-299 | SUSPENSION/ DROPS | 5 mg | OPHTHALMIC | NDA authorized generic | 10 sections |
| Loteprednol Etabonate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82260-508 | GEL | 5 mg | OPHTHALMIC | NDA authorized generic | 22 sections |