Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076419
Company: PADAGIS ISRAEL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO;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
01/07/2004 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076419.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/31/2015 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/18/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

02/04/2011 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

02/01/2008 SUPPL-4 Labeling

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 PADAGIS ISRAEL
KETOCONAZOLE KETOCONAZOLE 2% SHAMPOO;TOPICAL Prescription No AB 076942 TOLMAR

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