Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072933
Company: FOUGERA PHARMS INC

Products on ANDA 072933

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072933

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/30/1994	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072933

FLUOCINONIDE

GEL;TOPICAL; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	Yes	AB	017373	ALVOGEN
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	072933	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	074935	TARO