Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019591
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LARIAM MEFLOQUINE HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
05/02/1989 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2011 SUPPL-30 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019591s030ltr.pdf
08/20/2009 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf
06/26/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591slr027_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s027ltr.pdf
08/20/2009 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf
09/23/2008 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s024,019591s025ltr.pdf
09/23/2008 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s024,019591s025ltr.pdf
05/12/2008 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s023ltr.pdf
08/20/2003 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591slr022_lariam_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr022ltr.pdf
10/03/2002 SUPPL-20 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf
07/09/2003 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591s19lbl_Lariam.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr019ltr.pdf
06/21/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/2003 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf
03/24/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/2003 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf
11/10/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1999 SUPPL-12 Labeling

Label is not available on this site.

10/20/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/1999 SUPPL-10 Labeling

Label is not available on this site.

01/22/1996 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/16/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/06/1997 SUPPL-7 Labeling

Label is not available on this site.

11/03/1993 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1993 SUPPL-5 Labeling

Label is not available on this site.

10/04/1991 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1992 SUPPL-3 Efficacy-New Dosing Regimen

Label is not available on this site.

07/30/1990 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1990 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf
08/20/2009 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf
06/26/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591slr027_lbl.pdf
09/23/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf
09/23/2008 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf
05/12/2008 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf
08/20/2003 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591slr022_lariam_lbl.pdf
07/09/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591s19lbl_Lariam.pdf
01/10/2003 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf
01/10/2003 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf
10/03/2002 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf
05/02/1989 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf

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