Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076942
Company: TOLMAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription AB 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
04/11/2005 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076942_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/18/2020 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

08/31/2015 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

01/03/2013 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

10/17/2007 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

KETOCONAZOLE

SHAMPOO;TOPICAL; 2%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription No AB 076419 PERRIGO ISRAEL
KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription No AB 076942 TOLMAR
NIZORAL KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription Yes AB 019927 JANSSEN PHARMS

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