Details for New Drug Application (NDA): 076973
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NDA 076973 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 076973
| Tradename: | ALCLOMETASONE DIPROPIONATE |
| Applicant: | Fougera Pharms |
| Ingredient: | alclometasone dipropionate |
| Patents: | 0 |
Pharmacology for NDA: 076973
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076973
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALCLOMETASONE DIPROPIONATE | alclometasone dipropionate | CREAM;TOPICAL | 076973 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0263 | 0168-0263-15 | 15 g in 1 TUBE (0168-0263-15) |
| ALCLOMETASONE DIPROPIONATE | alclometasone dipropionate | CREAM;TOPICAL | 076973 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0263 | 0168-0263-45 | 45 g in 1 TUBE (0168-0263-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jul 12, 2005 | TE: | AB | RLD: | No | ||||
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