Details for New Drug Application (NDA): 216348
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NDA 216348 describes FLUOROMETHOLONE, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the FLUOROMETHOLONE profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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