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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076586
Company: FOUGERA PHARMS

Products on ANDA 076586

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINONIDE EMULSIFIED BASE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076586

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2004	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076586

FLUOCINONIDE EMULSIFIED BASE

CREAM;TOPICAL; 0.05%
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE EMULSIFIED BASE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	074204	COSETTE
FLUOCINONIDE EMULSIFIED BASE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	076586	FOUGERA PHARMS
FLUOCINONIDE EMULSIFIED BASE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	072494	TARO
FLUOCINONIDE EMULSIFIED BASE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB2	072490	TEVA

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