ATNAHS PHARMA US FDA Approval NDA 018164

NDA 018164

ATNAHS PHARMA US

FDA Drug Application

Application #018164

Documents

Letter2003-05-29
Letter2004-11-16
Letter2004-11-16
Letter2006-03-23
Letter2007-09-25
Letter2008-07-30
Label2008-07-29
Label2013-03-26
Label2016-05-11
Letter2006-01-30
Letter2007-04-25
Letter2013-03-26
Letter2016-05-11
Label2004-11-16
Label2004-11-16
Label2006-03-14
Label2006-01-25
Label2007-09-26
Other Important Information from FDA2005-07-28
Label2017-03-13
Letter2017-03-14
Letter2019-07-23
Medication Guide2019-07-23
Label2019-07-23
Letter2021-04-29
Label2021-04-30
Medication Guide2021-04-30

Application Sponsors

NDA 018164ATNAHS PHARMA US

Marketing Status

Discontinued001
Prescription003

Application Products

001TABLET;ORALEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ANAPROXNAPROXEN SODIUM
003TABLET;ORALEQ 500MG BASE1ANAPROX DSNAPROXEN SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1980-09-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1981-10-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1981-10-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1982-01-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1982-01-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1982-05-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1982-04-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1982-04-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1982-04-22STANDARD
LABELING; LabelingSUPPL12AP1983-09-09
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1982-10-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1985-04-23STANDARD
LABELING; LabelingSUPPL15AP1987-09-30
LABELING; LabelingSUPPL16AP1982-12-07
LABELING; LabelingSUPPL17AP1982-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1983-02-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1986-08-29STANDARD
LABELING; LabelingSUPPL21AP1983-09-09
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1985-04-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1987-09-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP1985-05-03STANDARD
LABELING; LabelingSUPPL31AP1985-09-24
MANUF (CMC); Manufacturing (CMC)SUPPL33AP1986-06-10STANDARD
LABELING; LabelingSUPPL34AP1987-09-30
EFFICACY; EfficacySUPPL35AP1987-09-30
EFFICACY; EfficacySUPPL36AP1987-09-30
MANUF (CMC); Manufacturing (CMC)SUPPL42AP1990-10-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL43AP1992-05-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL45AP1992-08-12STANDARD
LABELING; LabelingSUPPL46AP1993-12-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL47AP1995-02-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL48AP1994-09-06STANDARD
LABELING; LabelingSUPPL49AP2003-04-14STANDARD
LABELING; LabelingSUPPL50AP2004-11-10STANDARD
LABELING; LabelingSUPPL51AP2004-11-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL52AP2000-12-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL53AP2001-11-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL54AP2002-02-22STANDARD
LABELING; LabelingSUPPL55AP2006-03-10STANDARD
LABELING; LabelingSUPPL56AP2006-01-24STANDARD
LABELING; LabelingSUPPL57AP2007-04-19STANDARD
LABELING; LabelingSUPPL58AP2007-09-20STANDARD
LABELING; LabelingSUPPL60AP2008-07-25STANDARD
LABELING; LabelingSUPPL61AP2013-03-22STANDARD
LABELING; LabelingSUPPL62AP2016-05-09STANDARD
LABELING; LabelingSUPPL63AP2017-03-10STANDARD
LABELING; LabelingSUPPL64AP2019-07-22STANDARD
LABELING; LabelingSUPPL65AP2021-04-28STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL13Null0
SUPPL14Null0
SUPPL18Null0
SUPPL20Null0
SUPPL25Null0
SUPPL26Null0
SUPPL28Null0
SUPPL33Null0
SUPPL42Null0
SUPPL43Null0
SUPPL45Null0
SUPPL47Null0
SUPPL48Null0
SUPPL52Null0
SUPPL53Null0
SUPPL54Null0
SUPPL61Null6
SUPPL62Null6
SUPPL63Null6
SUPPL64Null7
SUPPL65Null15

TE Codes

003PrescriptionAB

CDER Filings

ATNAHS PHARMA US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18164
            [companyName] => ATNAHS PHARMA US
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/017581s115,018164s065,020067s024lbl.pdf#page=23"]
            [products] => [{"drugName":"ANAPROX","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ANAPROX DS","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/017581s115,018164s065,020067s024lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2019","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/017581s114,018164s064,020067s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2017","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017581s113,018164s063,020067s020lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017581s112,018164s062,020067s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-62","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/017581s112,018164s062,020067s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2013","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/017581s111,018164s061,018965s020,020067s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2008","submission":"SUPPL-60","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/017581s110,18164s60,18965s18,20067s17lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2007","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/017581s108,18164s58,18965s16,20067s14lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2006","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/24\/2006","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/017581s106,018164s056,018965s014,020067s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2004","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2004","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ANAPROX","submission":"NAPROXEN SODIUM","actionType":"EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ANAPROX DS","submission":"NAPROXEN SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-04-28
        )

)

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