Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076942
Company: TOLMAR

Products on ANDA 076942

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076942

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/11/2005	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076942_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2020	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
08/31/2015	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
01/03/2013	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
10/17/2007	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.

Therapeutic Equivalents for ANDA 076942

KETOCONAZOLE

SHAMPOO;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	No	AB	076419	PADAGIS ISRAEL
KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO;TOPICAL	Prescription	No	AB	076942	TOLMAR