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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019079

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NDA 019079 describes FLAREX, which is a drug marketed by Eyevance and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the fluorometholone acetate profile page.
Summary for 019079
Tradename:FLAREX
Applicant:Eyevance
Ingredient:fluorometholone acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019079
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 Alcon Laboratories, Inc. 0065-0096 0065-0096-05 1 BOTTLE, PLASTIC in 1 CARTON (0065-0096-05) > 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:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Feb 11, 1986TE:RLD:Yes

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