Details for New Drug Application (NDA): 208386
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The generic ingredient in FLUOCINOLONE ACETONIDE 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 208386
Tradename: | FLUOCINOLONE ACETONIDE |
Applicant: | Actavis Labs Ut Inc |
Ingredient: | fluocinolone acetonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208386
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 208386
Suppliers and Packaging for NDA: 208386
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | fluocinolone acetonide | SOLUTION;TOPICAL | 208386 | ANDA | Actavis Pharma, Inc. | 0591-2990 | 0591-2990-60 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0591-2990-60) / 60 mL in 1 BOTTLE, WITH APPLICATOR |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;TOPICAL | Strength | 0.01% | ||||
Approval Date: | Oct 21, 2016 | TE: | RLD: | No |
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