DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 202705
The generic ingredient in FLUOCINOLONE ACETONIDE 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 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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