Details for New Drug Application (NDA): 203378
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NDA 203378 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette, 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 are twelve 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 FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve 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 203378
| Tradename: | FLUOCINOLONE ACETONIDE |
| Applicant: | Rising |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 203378
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 203378
Suppliers and Packaging for NDA: 203378
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL/DROPS;OTIC | 203378 | ANDA | Rising Pharma Holdings, Inc. | 64980-329 | 64980-329-20 | 20 mL in 1 BOTTLE (64980-329-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OIL/DROPS;OTIC | Strength | 0.01% | ||||
| Approval Date: | Apr 25, 2016 | TE: | AT | RLD: | No | ||||
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