Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072537
Company: COSETTE

Products on ANDA 072537

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 072537

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/1989	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
10/23/2017	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
08/30/2001	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
02/26/2001	SUPPL-16	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
02/17/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/27/1997	SUPPL-14	Labeling		Label is not available on this site.
08/08/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/08/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/08/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/13/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/17/1996	SUPPL-9	Labeling		Label is not available on this site.
04/09/1996	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/04/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/31/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
06/30/1993	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/01/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072537

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	072537	COSETTE
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	072933	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	GEL;TOPICAL	Prescription	No	AB	074935	TARO