Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075581
Company: TEVA

Products on ANDA 075581

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 075581

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75581ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/30/2001	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 075581

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole_prntlbl.pdf

Therapeutic Equivalents for ANDA 075581

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	215185	PADAGIS US
KETOCONAZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075581	TEVA
KETOZOLE	KETOCONAZOLE	2%	CREAM;TOPICAL	Prescription	No	AB	075638	SUN PHARMA CANADA