Documents
Application Sponsors
| NDA 020067 | ATNAHS PHARMA US | |
Marketing Status
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 002 | TABLET, DELAYED RELEASE;ORAL | 375MG | 1 | EC-NAPROSYN | NAPROXEN |
| 003 | TABLET, DELAYED RELEASE;ORAL | 500MG | 1 | EC-NAPROSYN | NAPROXEN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1994-10-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1996-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1997-07-09 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2004-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2003-05-19 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2004-11-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2001-11-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-02-22 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2006-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2006-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2007-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2007-09-20 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2008-07-25 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2013-03-22 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2016-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2017-03-10 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2019-07-22 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 24 | Null | 15 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ATNAHS PHARMA US
cder:Array
(
[0] => Array
(
[ApplNo] => 20067
[companyName] => ATNAHS PHARMA US
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/017581s115,018164s065,020067s024lbl.pdf#page=23"]
[products] => [{"drugName":"EC-NAPROSYN","activeIngredients":"NAPROXEN","strength":"375MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"EC-NAPROSYN","activeIngredients":"NAPROXEN","strength":"500MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/28\/2021","submission":"SUPPL-24","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-21","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-20","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-19","supplementCategories":"Labeling-Medication Guide","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-19","supplementCategories":"Labeling-Package Insert","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-18","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-17","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-14","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-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/24\/2006","submission":"SUPPL-11","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-6","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-4","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":"EC-NAPROSYN","submission":"NAPROXEN","actionType":"375MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"EC-NAPROSYN","submission":"NAPROXEN","actionType":"500MG","submissionClassification":"TABLET, DELAYED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2021-04-28
)
)