Details for New Drug Application (NDA): 076367
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NDA 076367 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 076367
| Tradename: | AMCINONIDE |
| Applicant: | Taro Pharm Inds |
| Ingredient: | amcinonide |
| Patents: | 0 |
Pharmacology for NDA: 076367
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076367
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMCINONIDE | amcinonide | OINTMENT;TOPICAL | 076367 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4060 | 51672-4060-1 | 1 TUBE in 1 CARTON (51672-4060-1) / 15 g in 1 TUBE |
| AMCINONIDE | amcinonide | OINTMENT;TOPICAL | 076367 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-4060 | 51672-4060-2 | 1 TUBE in 1 CARTON (51672-4060-2) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Mar 19, 2003 | TE: | AB | RLD: | No | ||||
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