Details for New Drug Application (NDA): 210556
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NDA 210556 describes FLUCINOLONE ACETONIDE, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the FLUCINOLONE ACETONIDE profile page.
The generic ingredient in FLUCINOLONE 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.
The generic ingredient in FLUCINOLONE 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 210556
| Tradename: | FLUCINOLONE ACETONIDE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | fluocinolone acetonide |
| Patents: | 0 |
Pharmacology for NDA: 210556
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210556
Suppliers and Packaging for NDA: 210556
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUCINOLONE ACETONIDE | fluocinolone acetonide | OIL;TOPICAL | 210556 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-591 | 68462-591-89 | 1 BOTTLE in 1 CARTON (68462-591-89) / 118.28 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OIL;TOPICAL | Strength | 0.01% | ||||
| Approval Date: | Oct 25, 2018 | TE: | AT | RLD: | No | ||||
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