Details for New Drug Application (NDA): 019079
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NDA 019079 describes FLAREX, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from one supplier. Additional details are available on the FLAREX profile page.
The generic ingredient in FLAREX is fluorometholone acetate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluorometholone acetate profile page.
The generic ingredient in FLAREX is fluorometholone acetate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluorometholone acetate profile page.
Summary for 019079
| Tradename: | FLAREX |
| Applicant: | Harrow Eye |
| Ingredient: | fluorometholone acetate |
| Patents: | 0 |
Pharmacology for NDA: 019079
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 019079
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLAREX | fluorometholone acetate | SUSPENSION/DROPS;OPHTHALMIC | 019079 | NDA | Eyevance Pharmaceuticals | 71776-100 | 71776-100-03 | 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-03) / 2.5 mL in 1 BOTTLE, PLASTIC |
| FLAREX | fluorometholone acetate | SUSPENSION/DROPS;OPHTHALMIC | 019079 | NDA | Eyevance Pharmaceuticals | 71776-100 | 71776-100-05 | 1 BOTTLE, PLASTIC in 1 CARTON (71776-100-05) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1% | ||||
| Approval Date: | Feb 11, 1986 | TE: | RLD: | Yes | |||||
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