ALVOGEN FDA Approval NDA 020353

NDA 020353

ALVOGEN

FDA Drug Application

Application #020353

Documents

Letter2009-08-10
Letter2016-05-12
Letter2016-05-12
Label2016-05-11
Review2003-08-08
Letter2006-01-20
Letter2007-06-04
Letter2011-11-10
Label2006-01-20
Label2009-11-06
Label2011-11-09
Label2016-05-11
Medication Guide2011-11-17
Label2017-09-13
Letter2019-07-23
Label2019-07-23
Medication Guide2019-07-23
Letter2021-04-29
Label2021-05-03
Medication Guide2021-05-03

Application Sponsors

NDA 020353ALVOGEN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET, EXTENDED RELEASE;ORALEQ 375MG BASE1NAPRELANNAPROXEN SODIUM
002TABLET, EXTENDED RELEASE;ORALEQ 500MG BASE1NAPRELANNAPROXEN SODIUM
003TABLET, EXTENDED RELEASE;ORALEQ 750MG BASE1NAPRELANNAPROXEN SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1996-01-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-01-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-01-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-05-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1997-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-11-02STANDARD
LABELING; LabelingSUPPL8AP2002-02-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1999-07-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-02-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-06-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-06-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-10-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2002-04-15STANDARD
LABELING; LabelingSUPPL16AP2006-01-18STANDARD
LABELING; LabelingSUPPL19AP2007-05-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2009-07-08N/A
LABELING; LabelingSUPPL28AP2011-11-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2014-09-12STANDARD
LABELING; LabelingSUPPL31AP2016-05-09STANDARD
LABELING; LabelingSUPPL32AP2016-05-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL34AP2017-09-06N/A
LABELING; LabelingSUPPL36AP2019-07-22STANDARD
LABELING; LabelingSUPPL38AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null31
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL28Null7
SUPPL30Null0
SUPPL31Null15
SUPPL32Null6
SUPPL36Null6
SUPPL38Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALVOGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20353
            [companyName] => ALVOGEN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/020353s036lbl.pdf#page=21"]
            [products] => [{"drugName":"NAPRELAN","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 375MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"NAPRELAN","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"NAPRELAN","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 750MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/22\/2019","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020353s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2019","submission":"SUPPL-36","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020353s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2019","submission":"SUPPL-36","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020353s036lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2017","submission":"SUPPL-34","supplementCategories":"Manufacturing (CMC)-Facility","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020353s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020353s031s032lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-31","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020353s031s032lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020353s031s032lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2011","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020353s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2009","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/20353s23lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2009","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/20353s23lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2006","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020353s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NAPRELAN","submission":"NAPROXEN SODIUM","actionType":"EQ 375MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NAPRELAN","submission":"NAPROXEN SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NAPRELAN","submission":"NAPROXEN SODIUM","actionType":"EQ 750MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-07-22
        )

)
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