ABBOTT FDA Approval NDA 020632

NDA 020632

ABBOTT

FDA Drug Application

Application #020632

Documents

Letter2001-02-16
Letter2004-12-02
Letter2004-12-02
Letter2005-12-15
Letter2005-08-03
Letter2006-09-18
Letter2008-05-30
Label2004-12-03
Label2009-05-11
Review2008-02-19
Review2008-02-19
Review2008-02-19
Medication Guide2010-08-10
Letter2001-02-16
Letter2003-09-30
Letter2008-12-30
Letter2009-05-06
Letter2010-08-10
Letter2010-08-10
Label2001-02-16
Label2001-02-16
Label2005-12-15
Label2005-08-03
Label2006-08-29
Label2009-01-02
Label2010-08-10
Label2010-08-10
Review2003-06-17
Review2008-02-19
Review2008-02-19
Review2007-07-09
Medication Guide2010-08-10
Other Important Information from FDA2007-07-09
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Written Request1900-01-01
Pediatric Statistical Review2020-06-26

Application Sponsors

NDA 020632ABBOTT

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001CAPSULE;ORAL5MG0MERIDIASIBUTRAMINE HYDROCHLORIDE
002CAPSULE;ORAL10MG0MERIDIASIBUTRAMINE HYDROCHLORIDE
003CAPSULE;ORAL15MG0MERIDIASIBUTRAMINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1997-11-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-08-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-07-06STANDARD
LABELING; LabelingSUPPL6AP1999-11-12STANDARD
EFFICACY; EfficacySUPPL8AP2001-02-16STANDARD
EFFICACY; EfficacySUPPL11AP2001-02-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2002-04-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-08-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-10-08STANDARD
LABELING; LabelingSUPPL17AP2003-09-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2004-11-24STANDARD
LABELING; LabelingSUPPL20AP2004-11-24STANDARD
EFFICACY; EfficacySUPPL21AP2005-12-08STANDARD
LABELING; LabelingSUPPL24AP2005-07-29STANDARD
LABELING; LabelingSUPPL26AP2006-08-23STANDARD
LABELING; LabelingSUPPL30AP2008-05-29STANDARD
LABELING; LabelingSUPPL31AP2008-12-24STANDARD
LABELING; LabelingSUPPL32AP2009-05-04STANDARD
LABELING; LabelingSUPPL34AP2010-08-04STANDARD
LABELING; LabelingSUPPL35AP2010-08-04STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL6Null0
SUPPL8Null0
SUPPL11Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL17Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL24Null0
SUPPL26Null0
SUPPL30Null0
SUPPL31Null0
SUPPL32Null0
SUPPL34Null0
SUPPL35Null0

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20632
            [companyName] => ABBOTT
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2010\/020632s034s035MedGuide.pdf"]
            [products] => [{"drugName":"MERIDIA","activeIngredients":"SIBUTRAMINE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MERIDIA","activeIngredients":"SIBUTRAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MERIDIA","activeIngredients":"SIBUTRAMINE HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/04\/2010","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020632s034s035lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2010","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020632s034s035lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2009","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020632s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/24\/2008","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020632s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2006","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020632s026lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2005","submission":"SUPPL-21","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020632s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/29\/2005","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020632s024lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2004","submission":"SUPPL-19","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20632s019,020lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2001","submission":"SUPPL-11","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20632s8s11LBL.pdf\"}]","notes":""},{"actionDate":"02\/16\/2001","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20632s8s11LBL.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MERIDIA","submission":"SIBUTRAMINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MERIDIA","submission":"SIBUTRAMINE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MERIDIA","submission":"SIBUTRAMINE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-08-04
        )

)
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