ATNAHS PHARMA US FDA Approval NDA 018965

NDA 018965

ATNAHS PHARMA US

FDA Drug Application

Application #018965

Documents

Letter2004-11-16
Letter2004-11-16
Letter2007-09-25
Letter2008-07-30
Letter2016-05-12
Label2004-11-16
Label2006-03-14
Label2006-01-25
Label2007-09-26
Label2008-07-29
Label2013-03-26
Label2016-05-11
Letter2003-05-29
Letter2006-03-23
Letter2006-01-30
Letter2007-04-25
Letter2013-03-26
Letter2016-05-12
Label2004-11-16
Label2016-05-11
Label2017-03-13
Medication Guide2017-03-13
Letter2017-03-14
Letter2019-07-23
Label2019-07-23
Letter2021-04-29
Label2021-04-30
Medication Guide2021-04-30

Application Sponsors

NDA 018965ATNAHS PHARMA US

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL25MG/ML1NAPROSYNNAPROXEN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1987-03-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1993-01-27PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1994-09-12PRIORITY
LABELING; LabelingSUPPL7AP2003-04-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1996-11-14PRIORITY
LABELING; LabelingSUPPL9AP2004-11-10STANDARD
LABELING; LabelingSUPPL10AP2004-11-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-01-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2002-02-22PRIORITY
LABELING; LabelingSUPPL13AP2006-03-10STANDARD
LABELING; LabelingSUPPL14AP2006-01-24STANDARD
LABELING; LabelingSUPPL15AP2007-04-19STANDARD
LABELING; LabelingSUPPL16AP2007-09-20STANDARD
LABELING; LabelingSUPPL18AP2008-07-25STANDARD
LABELING; LabelingSUPPL20AP2013-03-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2015-07-30PRIORITY
LABELING; LabelingSUPPL22AP2016-05-09STANDARD
LABELING; LabelingSUPPL23AP2016-05-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2016-05-09PRIORITY
LABELING; LabelingSUPPL25AP2017-03-10STANDARD
LABELING; LabelingSUPPL26AP2019-07-22STANDARD
LABELING; LabelingSUPPL27AP2021-04-28STANDARD

Submissions Property Types

SUPPL4Null0
SUPPL6Null0
SUPPL8Null0
SUPPL11Null0
SUPPL12Null0
SUPPL20Null7
SUPPL21Null0
SUPPL22Null15
SUPPL23Null6
SUPPL24Null0
SUPPL25Null15
SUPPL26Null6
SUPPL27Null7

TE Codes

001PrescriptionAB

CDER Filings

ATNAHS PHARMA US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18965
            [companyName] => ATNAHS PHARMA US
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/018965s027lbl.pdf#page=23"]
            [products] => [{"drugName":"NAPROSYN","activeIngredients":"NAPROXEN","strength":"25MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/018965s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018965s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2017","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018965s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018965s022s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018965s022s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2016","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/018965s022s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2013","submission":"SUPPL-20","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-18","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-16","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-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/24\/2006","submission":"SUPPL-14","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-10","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-9","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":"NAPROSYN","submission":"NAPROXEN","actionType":"25MG\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-04-28
        )

)
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