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Details for New Drug Application (NDA): 074139
» See Plans and Pricing
NDA 074139 describes CLOBETASOL PROPIONATE, which is a drug marketed by Glenmark Pharms Ltd, Ingenus Pharms Llc, Perrigo Israel, Perrigo Uk Finco, Taro, Aleor Dermaceuticals, Amneal Pharms Llc, Cosette, Fougera Pharms Inc, Glenmark Pharms, Lupin Ltd, Mylan, Rising, Teligent Pharma Inc, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Fougera Pharms, Perrigo Co, Actavis Mid Atlantic, Cadila, Hi Tech, Encube, Novel Labs Inc, Macleods Pharms Ltd, Saptalis Pharms, Tolmar, Wockhardt Bio Ag, Akorn, Apotex, and Paddock Llc, and is included in seventy-one NDAs. It is available from forty-five 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. Fifty-two 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. Fifty-two suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.
Summary for 074139
| Tradename: | CLOBETASOL PROPIONATE |
| Applicant: | Cosette |
| Ingredient: | clobetasol propionate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074139
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 074139
Suppliers and Packaging for NDA: 074139
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 074139 | ANDA | Actavis Pharma, Inc. | 0472-0400 | 0472-0400-15 | 1 TUBE in 1 CARTON (0472-0400-15) > 15 g in 1 TUBE |
| CLOBETASOL PROPIONATE | clobetasol propionate | CREAM;TOPICAL | 074139 | ANDA | Actavis Pharma, Inc. | 0472-0400 | 0472-0400-30 | 1 TUBE in 1 CARTON (0472-0400-30) > 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Aug 3, 1994 | TE: | AB1 | RLD: | No | ||||
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