Details for New Drug Application (NDA): 076263
✉ Email this page to a colleague
NDA 076263 describes DIFLORASONE DIACETATE, which is a drug marketed by Ani Pharms, Avondale Pharms, Taro, Rising, Sciegen Pharms Inc, and The J Molner, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the DIFLORASONE DIACETATE profile page.
The generic ingredient in DIFLORASONE DIACETATE is diflorasone diacetate. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.
The generic ingredient in DIFLORASONE DIACETATE is diflorasone diacetate. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the diflorasone diacetate profile page.
Summary for 076263
| Tradename: | DIFLORASONE DIACETATE |
| Applicant: | Ani Pharms |
| Ingredient: | diflorasone diacetate |
| Patents: | 0 |
Pharmacology for NDA: 076263
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076263
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIFLORASONE DIACETATE | diflorasone diacetate | CREAM;TOPICAL | 076263 | ANDA | ANI Pharmaceuticals, Inc. | 62559-365 | 62559-365-26 | 6 TUBE in 1 CARTON (62559-365-26) / 2 g in 1 TUBE |
| DIFLORASONE DIACETATE | diflorasone diacetate | CREAM;TOPICAL | 076263 | ANDA | ANI Pharmaceuticals, Inc. | 62559-365 | 62559-365-30 | 1 TUBE in 1 CARTON (62559-365-30) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Dec 20, 2002 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
