DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 075057
NDA 075057 describes CLOBETASOL PROPIONATE, which is a drug marketed by Ingenus Pharms Llc, Perrigo Israel, Fougera Pharms Inc, G And W Labs Inc, Lupin Ltd, Mylan Pharms Inc, Taro, Teva Pharms Usa, Fougera Pharms, Perrigo Co, Teligent Pharma Inc, Actavis Mid Atlantic, Glenmark Pharms, Zydus Pharms Usa Inc, Hi-tech Pharmacal, Macleods Pharms Ltd, Novel Labs Inc, Tolmar, Wockhardt Bio Ag, Akorn, Paddock Llc, and Novast Labs Ltd, and is included in forty-five NDAs. It is available from thirty-two suppliers. Additional details are available on the CLOBETASOL PROPIONATE profile page.
The generic ingredient in CLOBETASOL PROPIONATE is clobetasol propionate. There are thirteen 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 thirteen 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 075057
| Tradename: | CLOBETASOL PROPIONATE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | clobetasol propionate |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) |
| 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 | N | 0378-8190-15 |
| CLOBETASOL PROPIONATE | clobetasol propionate | OINTMENT;TOPICAL | 075057 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8190 | N | 0378-8190-30 |
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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