Details for New Drug Application (NDA): 019216
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NDA 019216 describes FML FORTE, which is a drug marketed by Abbvie and is included in one NDA. It is available from one supplier. Additional details are available on the FML FORTE profile page.
The generic ingredient in FML FORTE 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 FML FORTE 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 019216
| Tradename: | FML FORTE |
| Applicant: | Abbvie |
| Ingredient: | fluorometholone |
| Patents: | 0 |
Pharmacology for NDA: 019216
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 019216
Suppliers and Packaging for NDA: 019216
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FML FORTE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 019216 | NDA | Allergan, Inc. | 11980-228 | 11980-228-05 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER |
| FML FORTE | fluorometholone | SUSPENSION/DROPS;OPHTHALMIC | 019216 | NDA | Allergan, Inc. | 11980-228 | 11980-228-10 | 1 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.25% | ||||
| Approval Date: | Apr 23, 1986 | TE: | RLD: | Yes | |||||
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