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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072641
Company: TARO

Products on ANDA 072641

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM;VAGINAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072641

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/1995	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
11/04/2002	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/2001	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/20/2000	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
11/20/2000	SUPPL-14	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
03/14/2000	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
03/14/2000	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/14/2000	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
03/14/2000	SUPPL-10	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/29/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/08/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/30/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/25/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/25/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/07/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/17/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

CLOTRIMAZOLE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CREAM;VAGINAL; 1%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM;VAGINAL	Over-the-counter	No	074165	P AND L
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM;VAGINAL	Over-the-counter	No	072641	TARO

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