Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073085
Company: COSETTE

Products on ANDA 073085

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073085

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/14/1992	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
07/05/2001	SUPPL-8	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/29/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/07/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
04/07/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/07/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/28/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/22/1993	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 073085

FLUOCINONIDE

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	210554	AMNEAL
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	073085	COSETTE
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	073030	FOUGERA PHARMS INC
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	071500	TARO
FLUOCINONIDE	FLUOCINONIDE	0.05%	CREAM;TOPICAL	Prescription	No	AB1	072488	TEVA