Details for New Drug Application (NDA): 209118
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The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 209118
Tradename: | FLUOCINONIDE |
Applicant: | Chartwell Rx |
Ingredient: | fluocinonide |
Patents: | 0 |
Pharmacology for NDA: 209118
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209118
Suppliers and Packaging for NDA: 209118
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | fluocinonide | SOLUTION;TOPICAL | 209118 | ANDA | Glasshouse Pharmaceuticals Limited Canada | 71428-001 | 71428-001-60 | 1 BOTTLE in 1 CARTON (71428-001-60) / 60 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 0.05% | ||||
Approval Date: | Apr 23, 2018 | TE: | AT | RLD: | No |
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