Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076523
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEFLOQUINE HYDROCHLORIDE MEFLOQUINE HYDROCHLORIDE 250MG 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
10/01/2004 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf
08/15/2011 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/18/2009 SUPPL-5 Labeling-Medication Guide

Label is not available on this site.

10/20/2009 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/19/2009 SUPPL-3 Labeling

Label is not available on this site.

09/18/2008 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/26/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076523s007lbl.pdf

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