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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090219
Company: GLENMARK PHARMS

Products on ANDA 090219

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2010	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090219

CLOTRIMAZOLE

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM;TOPICAL	Prescription	No	AB	078338	FOUGERA PHARMS
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM;TOPICAL	Prescription	No	AB	090219	GLENMARK PHARMS
CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM;TOPICAL	Prescription	No	AB	072640	TARO

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