Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076294
Company: FOUGERA PHARMS

Products on ANDA 076294

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076294

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2004	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
03/18/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076294

KETOCONAZOLE

CREAM;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	212443	ENCUBE
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	076294	FOUGERA PHARMS
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075581	TEVA
KETOZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075638	SUN PHARMA CANADA