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Last Updated: March 28, 2024

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.
Summary for 016851
Tradename:FML
Applicant:Abbvie
Ingredient:fluorometholone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016851
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:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Jul 28, 1982TE:ABRLD:Yes

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