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Generated: January 23, 2019

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Details for New Drug Application (NDA): 019079

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NDA 019079 describes FLAREX, which is a drug marketed by Novartis Pharms Corp 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.
Summary for 019079
Applicant:Novartis Pharms Corp
Ingredient:fluorometholone acetate
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

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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