Details for New Drug Application (NDA): 089524
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NDA 089524 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette Pharms Nc, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Sun Pharma Canada, Usl Pharma, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms, Tp Anda Holdings, Glenmark Pharms Ltd, 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-six NDAs. It is available from thirteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.
The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There is one drug master file entry for this compound. Nineteen 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 is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 089524
| Tradename: | FLUOCINOLONE ACETONIDE |
| Applicant: | Cosette Pharms Nc |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 089524
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 089524
Suppliers and Packaging for NDA: 089524
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OINTMENT;TOPICAL | 089524 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0224 | 0713-0224-15 | 1 TUBE in 1 CARTON (0713-0224-15) / 15 g in 1 TUBE |
| FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OINTMENT;TOPICAL | 089524 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0224 | 0713-0224-60 | 1 TUBE in 1 CARTON (0713-0224-60) / 60 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.025% | ||||
| Approval Date: | Jul 26, 1988 | TE: | AT | RLD: | No | ||||
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