Details for New Drug Application (NDA): 079227
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NDA 079227 describes ALCLOMETASONE DIPROPIONATE, which is a drug marketed by Fougera Pharms, Glenmark Pharms Ltd, and Taro, and is included in six NDAs. It is available from three suppliers. Additional details are available on the ALCLOMETASONE DIPROPIONATE profile page.
The generic ingredient in ALCLOMETASONE DIPROPIONATE is alclometasone dipropionate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alclometasone dipropionate profile page.
The generic ingredient in ALCLOMETASONE DIPROPIONATE is alclometasone dipropionate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alclometasone dipropionate profile page.
Summary for 079227
| Tradename: | ALCLOMETASONE DIPROPIONATE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | alclometasone dipropionate |
| Patents: | 0 |
Pharmacology for NDA: 079227
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 079227
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALCLOMETASONE DIPROPIONATE | alclometasone dipropionate | OINTMENT;TOPICAL | 079227 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-299 | 68462-299-17 | 15 g in 1 TUBE (68462-299-17) |
| ALCLOMETASONE DIPROPIONATE | alclometasone dipropionate | OINTMENT;TOPICAL | 079227 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-299 | 68462-299-47 | 45 g in 1 TUBE (68462-299-47) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jul 30, 2009 | TE: | AB | RLD: | No | ||||
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