Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019591
Company: ROCHE
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| LARIAM | MEFLOQUINE HYDROCHLORIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019591s030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s030.pdf |
| 08/20/2009 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s026;s028.pdf | |
| 06/26/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591slr027_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s027.pdf | |
| 08/20/2009 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s026;s028.pdf | |
| 09/23/2008 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s024,019591s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s025.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s023.pdf | |
| 08/20/2003 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s022.pdf | |
| 10/03/2002 | SUPPL-20 | Labeling |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s020.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s014;s017.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/019591Orig1s014;s017.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 |