Details for New Drug Application (NDA): 091282
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The generic ingredient in FLUOCINONIDE 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 091282
Tradename: | FLUOCINONIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | fluocinonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091282
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 091282
Suppliers and Packaging for NDA: 091282
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 091282 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-505 | 68462-505-35 | 30 g in 1 TUBE (68462-505-35) |
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 091282 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-505 | 68462-505-65 | 60 g in 1 TUBE (68462-505-65) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
Approval Date: | Jul 14, 2014 | TE: | AB | RLD: | No |
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