Details for New Drug Application (NDA): 090982
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The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 090982
Tradename: | FLUOCINOLONE ACETONIDE |
Applicant: | Lyne |
Ingredient: | fluocinolone acetonide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090982
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 090982
Suppliers and Packaging for NDA: 090982
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL;TOPICAL | 090982 | ANDA | A-S Medication Solutions | 50090-6780 | 50090-6780-0 | 118.28 mL in 1 BOTTLE (50090-6780-0) |
FLUOCINOLONE ACETONIDE | fluocinolone acetonide | OIL;TOPICAL | 090982 | ANDA | Rising Pharmaceuticals, Inc. | 64980-330 | 64980-330-04 | 118.28 mL in 1 BOTTLE (64980-330-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OIL;TOPICAL | Strength | 0.01% | ||||
Approval Date: | Apr 25, 2016 | TE: | AT | RLD: | No |
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