ABBVIE FDA Approval NDA 020381

NDA 020381

ABBVIE

FDA Drug Application

Application #020381

Documents

Letter1999-09-13
Letter2005-06-10
Letter2005-09-15
Letter2007-04-09
Letter2008-05-30
Letter2008-01-09
Letter2009-04-01
Letter2009-11-12
Letter2013-02-25
Letter2015-04-28
Label2005-06-10
Label2009-09-21
Label2010-03-03
Label2010-11-12
Letter1999-10-28
Letter2004-06-10
Letter2006-04-12
Letter2009-11-12
Letter2010-03-03
Letter2010-11-12
Label2003-03-05
Label2005-09-15
Label2006-04-12
Label2007-12-27
Label2009-09-21
Label2013-02-26
Label2015-04-27
Letter2020-09-10
Label2020-09-11
Letter2022-05-03
Label2022-05-04

Application Sponsors

NDA 020381ABBVIE

Marketing Status

Discontinued001
Prescription002
Prescription003
Prescription004
Discontinued005

Application Products

001TABLET, EXTENDED RELEASE;ORAL375MG0NIASPANNIACIN
002TABLET, EXTENDED RELEASE;ORAL500MG1NIASPANNIACIN
003TABLET, EXTENDED RELEASE;ORAL750MG1NIASPANNIACIN
004TABLET, EXTENDED RELEASE;ORAL1GM1NIASPANNIACIN
005TABLET, EXTENDED RELEASE;ORAL375MG;500MG;750MG0NIASPAN TITRATION STARTER PACKNIACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1997-07-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-03-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-05-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-08-24STANDARD
EFFICACY; EfficacySUPPL6AP1999-10-28STANDARD
EFFICACY; EfficacySUPPL7AP1999-09-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-05-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-06-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-08-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-08-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-11-24STANDARD
EFFICACY; EfficacySUPPL13AP2003-01-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-09-05STANDARD
LABELING; LabelingSUPPL20AP2005-06-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2005-09-09STANDARD
LABELING; LabelingSUPPL25AP2006-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2007-04-04STANDARD
LABELING; LabelingSUPPL32AP2008-05-29STANDARD
LABELING; LabelingSUPPL34AP2007-12-18STANDARD
LABELING; LabelingSUPPL38AP2009-03-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2009-09-16N/A
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2009-09-16N/A
LABELING; LabelingSUPPL42AP2010-02-24UNKNOWN
LABELING; LabelingSUPPL43AP2010-11-09UNKNOWN
LABELING; LabelingSUPPL48AP2013-02-21UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL49AP2013-06-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL50AP2015-05-27STANDARD
LABELING; LabelingSUPPL51AP2015-04-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL52AP2015-10-28STANDARD
LABELING; LabelingSUPPL54AP2020-09-09STANDARD
LABELING; LabelingSUPPL55AP2022-05-02STANDARD

Submissions Property Types

ORIG1Null31
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null31
SUPPL14Null0
SUPPL23Null0
SUPPL27Null0
SUPPL39Null7
SUPPL41Null7
SUPPL42Null6
SUPPL43Null6
SUPPL48Null15
SUPPL49Null0
SUPPL50Null0
SUPPL51Null15
SUPPL52Null0
SUPPL54Null7
SUPPL55Null15

TE Codes

002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20381
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIASPAN","activeIngredients":"NIACIN","strength":"375MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NIASPAN","activeIngredients":"NIACIN","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"NIASPAN","activeIngredients":"NIACIN","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"NIASPAN","activeIngredients":"NIACIN","strength":"1GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"NIASPAN TITRATION STARTER PACK","activeIngredients":"NIACIN","strength":"375MG;500MG;750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/09\/2020","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020381s054lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2015","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020381Orig1s051lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2013","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020381s048lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2010","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020381s043lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2010","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020381s042lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2009","submission":"SUPPL-41","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020381s039s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2009","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020381s039s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2009","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020381s039s041lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2007","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020381s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2006","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020381s025lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2005","submission":"SUPPL-23","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020381s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2005","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020381s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2003","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020381s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NIASPAN","submission":"NIACIN","actionType":"375MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NIASPAN","submission":"NIACIN","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NIASPAN","submission":"NIACIN","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NIASPAN","submission":"NIACIN","actionType":"1GM","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NIASPAN TITRATION STARTER PACK","submission":"NIACIN","actionType":"375MG;500MG;750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2020-09-09
        )

)
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.