Details for New Drug Application (NDA): 210539
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NDA 210539 describes FLUOCINONIDE ACETONIDE, which is a drug marketed by Glenmark Pharms Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the FLUOCINONIDE ACETONIDE profile page.
The generic ingredient in FLUOCINONIDE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
The generic ingredient in FLUOCINONIDE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 210539
| Tradename: | FLUOCINONIDE ACETONIDE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 210539
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210539
Suppliers and Packaging for NDA: 210539
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE ACETONIDE | fluocinolone acetonide | OIL;TOPICAL | 210539 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-590 | 68462-590-89 | 1 BOTTLE in 1 CARTON (68462-590-89) / 118.28 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | OIL;TOPICAL | Strength | 0.01% | ||||
| Approval Date: | Oct 26, 2018 | TE: | RLD: | No | |||||
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