Details for New Drug Application (NDA): 076065
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NDA 076065 describes AMCINONIDE, which is a drug marketed by Genus Lifesciences, Taro Pharm Inds, and Genus, and is included in five NDAs. It is available from four suppliers. Additional details are available on the AMCINONIDE profile page.
The generic ingredient in AMCINONIDE is amcinonide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amcinonide profile page.
The generic ingredient in AMCINONIDE is amcinonide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amcinonide profile page.
Summary for 076065
| Tradename: | AMCINONIDE |
| Applicant: | Genus Lifesciences |
| Ingredient: | amcinonide |
| Patents: | 0 |
Pharmacology for NDA: 076065
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076065
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMCINONIDE | amcinonide | CREAM;TOPICAL | 076065 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0278 | 0168-0278-15 | 1 TUBE in 1 CARTON (0168-0278-15) / 15 g in 1 TUBE |
| AMCINONIDE | amcinonide | CREAM;TOPICAL | 076065 | ANDA | Fougera Pharmaceuticals Inc. | 0168-0278 | 0168-0278-30 | 1 TUBE in 1 CARTON (0168-0278-30) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | May 15, 2003 | TE: | AB | RLD: | No | ||||
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