Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074204
Company: COSETTE

Products on ANDA 074204

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 074204

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/1995	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
12/29/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/28/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/23/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/23/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/23/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/23/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/01/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074204

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