Details for New Drug Application (NDA): 076096
NDA 076096 describes AMCINONIDE, which is a drug marketed by Genus Lifesciences, Taro Pharm Inds, Solubiomix, and Genus, and is included in five NDAs. It is available from three suppliers. Additional details are available on the AMCINONIDE profile page.
The generic ingredient in AMCINONIDE is amcinonide. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amcinonide profile page.
The generic ingredient in AMCINONIDE is amcinonide. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the amcinonide profile page.
Summary for 076096
| Tradename: | AMCINONIDE |
| Applicant: | Genus |
| Ingredient: | amcinonide |
| Patents: | 0 |
Pharmacology for NDA: 076096
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 076096
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMCINONIDE | amcinonide | OINTMENT;TOPICAL | 076096 | ANDA | Ayurax, LLC | 73308-407 | 73308-407-60 | 1 TUBE in 1 CARTON (73308-407-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.1% | ||||
| Approval Date: | Nov 19, 2002 | TE: | RLD: | No | |||||
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