Details for New Drug Application (NDA): 076587
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NDA 076587 describes ALCLOMETASONE DIPROPIONATE, which is a drug marketed by Fougera Pharms, Glenmark Pharms Ltd, and Sun Pharma Canada, 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 076587
| Tradename: | ALCLOMETASONE DIPROPIONATE |
| Applicant: | Sun Pharma Canada |
| Ingredient: | alclometasone dipropionate |
| Patents: | 0 |
Pharmacology for NDA: 076587
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076587
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALCLOMETASONE DIPROPIONATE | alclometasone dipropionate | CREAM;TOPICAL | 076587 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1306 | 51672-1306-1 | 1 TUBE in 1 CARTON (51672-1306-1) / 15 g in 1 TUBE |
| ALCLOMETASONE DIPROPIONATE | alclometasone dipropionate | CREAM;TOPICAL | 076587 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1306 | 51672-1306-3 | 1 TUBE in 1 CARTON (51672-1306-3) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Sep 15, 2005 | TE: | AB | RLD: | No | ||||
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