Details for New Drug Application (NDA): 090256
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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 090256
Tradename: | FLUOCINONIDE |
Applicant: | Padagis Israel |
Ingredient: | fluocinonide |
Patents: | 0 |
Pharmacology for NDA: 090256
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 090256
Suppliers and Packaging for NDA: 090256
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 090256 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-151 | 45802-151-53 | 1 TUBE in 1 CARTON (45802-151-53) / 120 g in 1 TUBE |
FLUOCINONIDE | fluocinonide | CREAM;TOPICAL | 090256 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-151 | 45802-151-94 | 1 TUBE in 1 CARTON (45802-151-94) / 30 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;TOPICAL | Strength | 0.1% | ||||
Approval Date: | Jan 14, 2014 | TE: | RLD: | No |
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