Details for New Drug Application (NDA): 206003
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NDA 206003 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-seven 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-three 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-three suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 206003
| Tradename: | FLUOCINONIDE |
| Applicant: | Novel Labs Inc |
| Ingredient: | fluocinonide |
| Patents: | 0 |
Pharmacology for NDA: 206003
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 206003
Suppliers and Packaging for NDA: 206003
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 206003 | ANDA | Novel Laboratories, Inc. | 40032-026 | 40032-026-06 | 1 BOTTLE in 1 CARTON (40032-026-06) / 60 mL in 1 BOTTLE |
| FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 206003 | ANDA | Lupin Pharmaceuticals,Inc. | 43386-026 | 43386-026-02 | 1 BOTTLE in 1 CARTON (43386-026-02) / 20 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | Jul 21, 2017 | TE: | AT | RLD: | No | ||||
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