Details for New Drug Application (NDA): 210554
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NDA 210554 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, and Zydus Pharms, and is included in forty-four NDAs. It is available from twenty-nine suppliers. Additional details are available on the FLUOCINONIDE profile page.
The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two 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 twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 210554
| Tradename: | FLUOCINONIDE |
| Applicant: | Amneal |
| Ingredient: | fluocinonide |
| Patents: | 0 |
Pharmacology for NDA: 210554
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210554
Suppliers and Packaging for NDA: 210554
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 210554 | ANDA | A-S Medication Solutions | 50090-6309 | 50090-6309-0 | 1 TUBE in 1 CARTON (50090-6309-0) / 30 g in 1 TUBE |
| FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 210554 | ANDA | NuCare Pharmceuticals,Inc. | 68071-2667 | 68071-2667-5 | 1 TUBE in 1 CARTON (68071-2667-5) / 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Aug 21, 2018 | TE: | AB1 | RLD: | No | ||||
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