DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 202705
NDA 202705 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs, Perrigo New York, Pharmaderm, Pharmafair, Taro, Usl Pharma, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Actavis Labs Ut Inc, Bausch And Lomb, G And W Labs Inc, Gavis Pharms Llc, Glasshouse Pharms, and Morton Grove, and is included in forty-seven 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-four 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-four suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 202705
| Tradename: | FLUOCINOLONE ACETONIDE |
| Applicant: | Akorn |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal) Ophthalmic Agents Otic Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202705
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 202705
Suppliers and Packaging for NDA: 202705
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL/DROPS;OTIC | 202705 | ANDA | VersaPharm Incorporated | 61748-250 | N | 61748-250-20 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OIL/DROPS;OTIC | Strength | 0.01% | ||||
| Approval Date: | Sep 9, 2016 | TE: | AT | RLD: | No | ||||
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