Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076175
Company: SANDOZ
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
02/20/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76175_Mefloquine Hydrochloride_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76175.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/076175_mefloquine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2016 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-30 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076175s030lbl.pdf
09/02/2011 SUPPL-26 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/076175s026lbl.pdf
10/19/2009 SUPPL-25 Labeling-Patient Package Insert

Label is not available on this site.

01/15/2009 SUPPL-22 Labeling

Label is not available on this site.

09/18/2008 SUPPL-21 Labeling

Label is not available on this site.

04/09/2004 SUPPL-10 Labeling

Label is not available on this site.

10/24/2003 SUPPL-8 Labeling

Label is not available on this site.

10/29/2002 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-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076175s030lbl.pdf
09/02/2011 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/076175s026lbl.pdf
02/20/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/76175_Mefloquine Hydrochloride_Prntlbl.pdf

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