Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075319
Company: TARO

Products on ANDA 075319

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1999	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75319ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2023	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/15/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/25/2017	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/25/2017	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075319

KETOCONAZOLE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	075912	SENORES PHARMS
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	210457	STRIDES PHARMA
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	075319	TARO