ROCHE FDA Approval NDA 019591

NDA 019591

ROCHE

FDA Drug Application

Application #019591

Documents

Letter2003-01-10
Letter2003-09-08
Letter2008-09-26
Label2002-10-04
Label2003-09-08
Label2003-09-08
Label2008-06-05
Label2009-09-17
Label2009-07-24
Label2009-09-17
Letter2003-01-10
Letter2003-07-10
Letter2008-05-14
Letter2008-09-26
Letter2009-11-19
Letter2009-06-30
Letter2009-11-19
Letter2011-05-04
Label2003-01-10
Label2003-01-10
Label2003-07-09
Label2008-10-03
Label2008-10-03
Medication Guide2009-09-25
Medication Guide2018-11-08
Review2022-10-12
Review2022-10-19
Review2022-10-19
Review2022-10-19
Review2022-10-19
Review2022-10-19
Review2022-10-19
Review2022-10-19
Review2022-10-19
Review2022-10-19

Application Sponsors

NDA 019591ROCHE

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1LARIAMMEFLOQUINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1989-05-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1990-07-30STANDARD
EFFICACY; EfficacySUPPL3AP1992-11-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1991-10-04STANDARD
LABELING; LabelingSUPPL5AP1993-11-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-11-03STANDARD
LABELING; LabelingSUPPL7AP1997-08-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1995-06-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1996-01-22STANDARD
LABELING; LabelingSUPPL10AP1999-08-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1998-10-20STANDARD
LABELING; LabelingSUPPL12AP1999-08-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1999-11-10STANDARD
LABELING; LabelingSUPPL14AP2003-01-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-03-24STANDARD
LABELING; LabelingSUPPL17AP2003-01-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-06-21STANDARD
LABELING; LabelingSUPPL19AP2003-07-09STANDARD
LABELING; LabelingSUPPL20AP2002-10-03STANDARD
LABELING; LabelingSUPPL22AP2003-08-20STANDARD
LABELING; LabelingSUPPL23AP2008-05-12STANDARD
LABELING; LabelingSUPPL24AP2008-09-23STANDARD
LABELING; LabelingSUPPL25AP2008-09-23STANDARD
LABELING; LabelingSUPPL26AP2009-08-20STANDARD
LABELING; LabelingSUPPL27AP2009-06-26STANDARD
LABELING; LabelingSUPPL28AP2009-08-20STANDARD
LABELING; LabelingSUPPL30AP2011-04-29STANDARD

Submissions Property Types

ORIG1Null14
SUPPL2Null14
SUPPL3Null14
SUPPL4Null14
SUPPL5Null14
SUPPL6Null14
SUPPL7Null14
SUPPL8Null14
SUPPL9Null14
SUPPL10Null14
SUPPL11Null14
SUPPL12Null14
SUPPL13Null14
SUPPL14Null14
SUPPL15Null14
SUPPL17Null14
SUPPL18Null14
SUPPL19Null14
SUPPL20Null14
SUPPL22Null14
SUPPL23Null14
SUPPL24Null14
SUPPL25Null14
SUPPL26Null14
SUPPL27Null14
SUPPL28Null14
SUPPL30Null14

CDER Filings

ROCHE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19591
            [companyName] => ROCHE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2009\/019591s026s028lbl.pdf#page=13"]
            [products] => [{"drugName":"LARIAM","activeIngredients":"MEFLOQUINE HYDROCHLORIDE","strength":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"08\/20\/2009","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019591s026s028lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019591s026s028lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2009","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019591slr027_lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2008","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019591s024s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2008","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019591s024s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2008","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019591s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2003","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19591slr022_lariam_lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2003","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19591s19lbl_Lariam.pdf\"}]","notes":""},{"actionDate":"01\/10\/2003","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019591s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2003","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/019591s014lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2002","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19591s20lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/1989","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19591s20lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LARIAM","submission":"MEFLOQUINE HYDROCHLORIDE","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-08-20
        )

)
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