Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076175
Company: SANDOZ
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 |