Details for New Drug Application (NDA): 209913
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NDA 209913 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Amneal, Lyne, Padagis Israel, Quagen, Sciegen Pharms Inc, Trupharma, Novel Labs Inc, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in fifty-five NDAs. It is available from fourteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.
The generic ingredient in FLUOCINOLONE ACETONIDE 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 FLUOCINOLONE ACETONIDE 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 209913
| Tradename: | FLUOCINOLONE ACETONIDE |
| Applicant: | Encube Ethicals |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 209913
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209913
Suppliers and Packaging for NDA: 209913
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | fluocinolone acetonide | SOLUTION;TOPICAL | 209913 | ANDA | Encube Ethicals Private Limited | 21922-003 | 21922-003-01 | 1 BOTTLE in 1 CARTON (21922-003-01) / 60 mL in 1 BOTTLE |
| FLUOCINOLONE ACETONIDE | fluocinolone acetonide | SOLUTION;TOPICAL | 209913 | ANDA | Bryant Ranch Prepack | 63629-9584 | 63629-9584-1 | 1 BOTTLE in 1 CARTON (63629-9584-1) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.01% | ||||
| Approval Date: | Feb 13, 2019 | TE: | AT | RLD: | No | ||||
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