Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072494
Company: TARO

Products on ANDA 072494

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072494

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/19/1989	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
04/13/2004	SUPPL-7	Labeling		Label is not available on this site.
09/13/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/06/1995	SUPPL-3	Labeling		Label is not available on this site.
05/15/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/11/1991	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072494

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