SANOFI AVENTIS US FDA Approval NDA 020579

NDA 020579

SANOFI AVENTIS US

FDA Drug Application

Application #020579

Documents

Letter2005-10-25
Letter2007-01-16
Letter2008-05-05
Letter2009-11-19
Letter2011-07-27
Letter2014-10-22
Label2007-01-16
Label2007-02-21
Label2009-10-30
Label2010-01-04
Label2011-07-27
Letter2007-02-23
Letter2008-12-04
Letter2009-12-29
Letter2014-07-24
Label2005-10-24
Label2014-07-24
Label2014-10-21
Review2010-03-16
Pediatric Written Request2009-09-17
Pediatric Amendment 12009-09-17
Pediatric Amendment 22009-09-17
Pediatric Amendment 32009-09-17
Pediatric Statistical Review2009-09-17
Pediatric Clinical Pharmacology Review2009-09-17
Pediatric Medical Review2009-09-17
Label2019-01-25
Letter2019-02-13

Application Sponsors

NDA 020579SANOFI AVENTIS US

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL0.4MG1FLOMAXTAMSULOSIN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1997-04-15STANDARD
LABELING; LabelingSUPPL2AP1998-05-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-12-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-01-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-02-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-09-02STANDARD
LABELING; LabelingSUPPL7AP2001-05-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-06-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-07-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2001-06-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-08-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-12-17STANDARD
LABELING; LabelingSUPPL16AP2005-10-18STANDARD
LABELING; LabelingSUPPL17AP2005-10-18STANDARD
LABELING; LabelingSUPPL20AP2007-01-11STANDARD
LABELING; LabelingSUPPL21AP2007-02-16STANDARD
LABELING; LabelingSUPPL23AP2008-04-29STANDARD
LABELING; LabelingSUPPL24AP2008-12-02STANDARD
LABELING; LabelingSUPPL25AP2009-10-29STANDARD
EFFICACY; EfficacySUPPL26AP2009-12-22PRIORITY
LABELING; LabelingSUPPL27AP2011-07-25UNKNOWN
LABELING; LabelingSUPPL28AP2014-07-20STANDARD
LABELING; LabelingSUPPL29AP2014-10-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL31AP2016-01-21STANDARD
LABELING; LabelingSUPPL33AP2019-01-23STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL25Null6
SUPPL26Null6
SUPPL27Null7
SUPPL28Null7
SUPPL29Null15
SUPPL31Null0
SUPPL33Null7

TE Codes

001PrescriptionAB

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20579
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLOMAX","activeIngredients":"TAMSULOSIN HYDROCHLORIDE","strength":"0.4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/23\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020579s033lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2014","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020579s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020579s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020579s028lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2011","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020579s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2009","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020579s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2009","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020579s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2007","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020579s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2007","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020579s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020579s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLOMAX","submission":"TAMSULOSIN HYDROCHLORIDE","actionType":"0.4MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-23
        )

)
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