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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075273
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOCONAZOLE KETOCONAZOLE 200MG TABLET;ORAL Discontinued None No No
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/99/75-273_Ketoconazole_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75273ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-273_Ketoconazole.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2020 SUPPL-18 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/15/2017 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

10/25/2017 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

10/25/2017 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/30/2001 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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/99/75-273_Ketoconazole_prntlbl.pdf
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