Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074580
Company: SUN PHARMA CANADA

Products on ANDA 074580

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1996	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
09/11/2003	SUPPL-6	Labeling		Label is not available on this site.
11/04/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
01/18/2001	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/08/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074580

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