Details for New Drug Application (NDA): 218819
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NDA 218819 describes FLUOROMETHOLONE, which is a drug marketed by Amneal and Difgen Pharms and is included in two NDAs. It is available from two suppliers. 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the fluorometholone profile page.
Summary for 218819
| Tradename: | FLUOROMETHOLONE |
| Applicant: | Difgen Pharms |
| Ingredient: | fluorometholone |
| Patents: | 0 |
Pharmacology for NDA: 218819
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 218819
Suppliers and Packaging for NDA: 218819
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOROMETHOLONE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 218819 | ANDA | Sandoz Inc | 0781-6187 | 0781-6187-70 | 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-70) / 10 mL in 1 BOTTLE, DROPPER |
| FLUOROMETHOLONE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 218819 | ANDA | Sandoz Inc | 0781-6187 | 0781-6187-75 | 1 BOTTLE, DROPPER in 1 CARTON (0781-6187-75) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
| Approval Date: | Feb 12, 2026 | TE: | AB | RLD: | No | ||||
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