Details for New Drug Application (NDA): 016851
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NDA 016851 describes FML, which is a drug marketed by Allergan and Abbvie and is included in four NDAs. It is available from two suppliers. Additional details are available on the FML profile page.
The generic ingredient in FML is fluorometholone; sulfacetamide sodium. There are five drug master file entries for this compound. Additional details are available on the fluorometholone; sulfacetamide sodium profile page.
The generic ingredient in FML is fluorometholone; sulfacetamide sodium. There are five drug master file entries for this compound. Additional details are available on the fluorometholone; sulfacetamide sodium profile page.
Summary for 016851
| Tradename: | FML |
| Applicant: | Abbvie |
| Ingredient: | fluorometholone |
| Patents: | 0 |
Pharmacology for NDA: 016851
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 016851
Suppliers and Packaging for NDA: 016851
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FML | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 016851 | NDA | Allergan, Inc. | 11980-211 | 11980-211-05 | 1 BOTTLE, DROPPER in 1 CARTON (11980-211-05) / 5 mL in 1 BOTTLE, DROPPER |
| FML | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 016851 | NDA | Allergan, Inc. | 11980-211 | 11980-211-10 | 1 BOTTLE, DROPPER in 1 CARTON (11980-211-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
| Approval Date: | Jul 28, 1982 | TE: | AB | RLD: | Yes | ||||
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