Details for New Drug Application (NDA): 218158
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NDA 218158 describes CLOBETASOL PROPIONATE, which is a drug marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Speclt, Lupin Ltd, Pai Holdings Pharm, Rising, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Macleods Pharms Ltd, Novel Labs Inc, Hikma, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms Inc, Eyenovia, and Ani Pharms, and is included in eighty-one NDAs. It is available from thirty-seven suppliers. There are two patents protecting this drug. Additional details are available on the CLOBETASOL PROPIONATE profile page.
The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 218158
| Tradename: | CLOBETASOL PROPIONATE |
| Applicant: | Eyenovia |
| Ingredient: | clobetasol propionate |
| Patents: | 2 |
Pharmacology for NDA: 218158
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 218158
Suppliers and Packaging for NDA: 218158
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | clobetasol propionate | SUSPENSION/DROPS;OPHTHALMIC | 218158 | NDA | Eyenovia, Inc. | 81046-0319 | 81046-0319-1 | 1 BOTTLE, DROPPER in 1 CARTON (81046-0319-1) / 3.5 mL in 1 BOTTLE, DROPPER |
| CLOBETASOL PROPIONATE | clobetasol propionate | SUSPENSION/DROPS;OPHTHALMIC | 218158 | NDA | Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant | 81772-007 | 81772-007-01 | 1 BOTTLE, DROPPER in 1 CARTON (81772-007-01) / 3.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
| Approval Date: | Mar 4, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 4, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 9, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF INFLAMMATION | ||||||||
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