Details for New Drug Application (NDA): 209699
NDA 209699 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette Pharms Nc, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Perrigo New York, Sun Pharma Canada, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Pai Holdings Pharm, Xiromed, Encube Ethicals, Macleods Pharms, Novel Labs Inc, Quagen, Sciegen Pharms, Teva Pharms, Zydus Pharms, and Taro, and is included in forty-five NDAs. It is available from twenty-four suppliers. Additional details are available on the FLUOCINONIDE profile page.
The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 209699
| Tradename: | FLUOCINONIDE |
| Applicant: | Encube Ethicals |
| Ingredient: | fluocinonide |
| Patents: | 0 |
Pharmacology for NDA: 209699
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209699
Suppliers and Packaging for NDA: 209699
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 209699 | ANDA | Encube Ethicals, Inc. | 21922-001 | 21922-001-01 | 1 BOTTLE in 1 CARTON (21922-001-01) / 60 mL in 1 BOTTLE |
| FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 209699 | ANDA | Bryant Ranch Prepack | 63629-9583 | 63629-9583-1 | 1 BOTTLE in 1 CARTON (63629-9583-1) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Nov 29, 2018 | TE: | AT | RLD: | No | ||||
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