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Details for New Drug Application (NDA): 075057
NDA 075057 describes CLOBETASOL PROPIONATE, which is a drug marketed by Ingenus Pharms Llc, Perrigo Israel, Taro Pharm, Chemo Research Sl, Fougera Pharms Inc, G And W Labs Inc, Glenmark Pharms, Lupin Ltd, Mylan Pharms Inc, Taro, Teligent Pharma Inc, Teva Pharms Usa, Zydus Pharms Usa Inc, Fougera Pharms, Perrigo Co, Actavis Mid Atlantic, Hi-tech Pharmacal, Amneal Pharms Llc, Novel Labs Inc, Glenmark Pharms Ltd, Macleods Pharms Ltd, Tolmar, Wockhardt Bio Ag, Akorn, Apotex Inc, Paddock Llc, and Novast Labs, and is included in fifty-six NDAs. It is available from thirty-seven suppliers. 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-five 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-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 075057
| Tradename: | CLOBETASOL PROPIONATE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | clobetasol propionate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075057
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 075057
Suppliers and Packaging for NDA: 075057
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 075057 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8190 | 0378-8190-15 | 1 TUBE in 1 CARTON (0378-8190-15) > 15 g in 1 TUBE |
| CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 075057 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8190 | 0378-8190-30 | 1 TUBE in 1 CARTON (0378-8190-30) > 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Aug 12, 1998 | TE: | AB | RLD: | No | ||||
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