Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074971
Company: CHARTWELL RX

Products on ANDA 074971

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074971

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			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-971_Ketoconazole_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74971ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-971_Ketoconazole.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/16/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/01/2023	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
02/18/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/15/2017	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 074971

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/74-971_Ketoconazole_prntlbl.pdf