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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073306
Company: TEVA

Products on ANDA 073306

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073306

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/1995	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
12/20/2002	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/29/2002	SUPPL-9	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
08/30/2001	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
02/04/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/04/2000	SUPPL-4	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/28/1998	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.
10/18/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073306

CLOTRIMAZOLE

SOLUTION;TOPICAL; 1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	209815	NOVITIUM PHARMA
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	216569	SCIEGEN PHARMS
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	074580	SUN PHARMA CANADA
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	073306	TEVA
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	SOLUTION;TOPICAL	Prescription	No	AT	212281	TP ANDA HOLDINGS

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