Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 078338
Company: FOUGERA PHARMS

Products on ANDA 078338

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 078338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/2008	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078338

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	SUN PHARMA CANADA