Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075581
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOCONAZOLE KETOCONAZOLE 2% CREAM;TOPICAL 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
04/25/2000 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75581ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/30/2001 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
04/25/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-581_Ketoconazole_prntlbl.pdf

KETOCONAZOLE

CREAM;TOPICAL; 2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETOCONAZOLE KETOCONAZOLE 2% CREAM;TOPICAL Prescription No AB 212443 ENCUBE
KETOCONAZOLE KETOCONAZOLE 2% CREAM;TOPICAL Prescription No AB 076294 FOUGERA PHARMS
KETOCONAZOLE KETOCONAZOLE 2% CREAM;TOPICAL Prescription No AB 075581 TEVA
KETOZOLE KETOCONAZOLE 2% CREAM;TOPICAL Prescription No AB 075638 TARO

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