Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075319
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOCONAZOLE KETOCONAZOLE 200MG TABLET;ORAL Prescription AB No Yes
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
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.

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

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