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 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 218819
| Tradename: | FLUOROMETHOLONE |
| Applicant: | Difgen Pharms |
| Ingredient: | fluorometholone |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 218819
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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