Details for New Drug Application (NDA): 212976
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The generic ingredient in FLUOCINONIDE 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 212976
Tradename: | FLUOCINONIDE |
Applicant: | Xiromed |
Ingredient: | fluocinonide |
Patents: | 0 |
Pharmacology for NDA: 212976
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 212976
Suppliers and Packaging for NDA: 212976
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | OINTMENT;TOPICAL | 212976 | ANDA | Bryant Ranch Prepack | 63629-2337 | 63629-2337-1 | 1 TUBE in 1 CARTON (63629-2337-1) / 60 g in 1 TUBE |
FLUOCINONIDE | fluocinonide | OINTMENT;TOPICAL | 212976 | ANDA | Bryant Ranch Prepack | 63629-2338 | 63629-2338-1 | 1 TUBE in 1 CARTON (63629-2338-1) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Nov 26, 2019 | TE: | AB | RLD: | No |
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