Details for New Drug Application (NDA): 216348
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The generic ingredient in FLUOROMETHOLONE is fluorometholone. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluorometholone profile page.
Summary for 216348
Tradename: | FLUOROMETHOLONE |
Applicant: | Amneal |
Ingredient: | fluorometholone |
Patents: | 0 |
Pharmacology for NDA: 216348
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 216348
Suppliers and Packaging for NDA: 216348
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FLUOROMETHOLONE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 216348 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1585 | 60219-1585-3 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER |
FLUOROMETHOLONE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 216348 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1586 | 60219-1586-6 | 1 BOTTLE, DROPPER in 1 CARTON (60219-1586-6) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
Approval Date: | Jan 9, 2024 | TE: | AB | RLD: | No | ||||
Regulatory Exclusivity Expiration: | Jul 7, 2024 | ||||||||
Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY |
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