Details for New Drug Application (NDA): 210554
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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 210554
Tradename: | FLUOCINONIDE |
Applicant: | Amneal |
Ingredient: | fluocinonide |
Patents: | 0 |
Pharmacology for NDA: 210554
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210554
Suppliers and Packaging for NDA: 210554
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 210554 | ANDA | A-S Medication Solutions | 50090-6309 | 50090-6309-0 | 1 TUBE in 1 CARTON (50090-6309-0) / 30 g in 1 TUBE |
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 210554 | ANDA | NuCare Pharmceuticals,Inc. | 68071-2667 | 68071-2667-5 | 1 TUBE in 1 CARTON (68071-2667-5) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Aug 21, 2018 | TE: | AB1 | RLD: | No |
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