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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 017760

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NDA 017760 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 017760

Tradename:	FML
Applicant:	Allergan
Ingredient:	fluorometholone
Patents:	0

Medical Subject Heading (MeSH) Categories for 017760

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC			Strength	0.1%
Approval Date:	Sep 4, 1985	TE:		RLD:	Yes

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