Documents
Application Sponsors
NDA 018164 | ATNAHS PHARMA US | |
Marketing Status
Discontinued | 001 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ANAPROX | NAPROXEN SODIUM |
003 | TABLET;ORAL | EQ 500MG BASE | 1 | ANAPROX DS | NAPROXEN SODIUM |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1980-09-04 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1981-10-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1981-10-13 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1982-01-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-01-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1982-05-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1982-04-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1982-04-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1982-04-22 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 1983-09-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1982-10-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1985-04-23 | STANDARD |
LABELING; Labeling | SUPPL | 15 | AP | 1987-09-30 | |
LABELING; Labeling | SUPPL | 16 | AP | 1982-12-07 | |
LABELING; Labeling | SUPPL | 17 | AP | 1982-12-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1983-02-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1986-08-29 | STANDARD |
LABELING; Labeling | SUPPL | 21 | AP | 1983-09-09 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1985-04-29 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1987-09-30 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1985-05-03 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 1985-09-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1986-06-10 | STANDARD |
LABELING; Labeling | SUPPL | 34 | AP | 1987-09-30 | |
EFFICACY; Efficacy | SUPPL | 35 | AP | 1987-09-30 | |
EFFICACY; Efficacy | SUPPL | 36 | AP | 1987-09-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1990-10-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1992-05-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1992-08-12 | STANDARD |
LABELING; Labeling | SUPPL | 46 | AP | 1993-12-15 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1995-02-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1994-09-06 | STANDARD |
LABELING; Labeling | SUPPL | 49 | AP | 2003-04-14 | STANDARD |
LABELING; Labeling | SUPPL | 50 | AP | 2004-11-10 | STANDARD |
LABELING; Labeling | SUPPL | 51 | AP | 2004-11-10 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 52 | AP | 2000-12-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 2001-11-09 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 54 | AP | 2002-02-22 | STANDARD |
LABELING; Labeling | SUPPL | 55 | AP | 2006-03-10 | STANDARD |
LABELING; Labeling | SUPPL | 56 | AP | 2006-01-24 | STANDARD |
LABELING; Labeling | SUPPL | 57 | AP | 2007-04-19 | STANDARD |
LABELING; Labeling | SUPPL | 58 | AP | 2007-09-20 | STANDARD |
LABELING; Labeling | SUPPL | 60 | AP | 2008-07-25 | STANDARD |
LABELING; Labeling | SUPPL | 61 | AP | 2013-03-22 | STANDARD |
LABELING; Labeling | SUPPL | 62 | AP | 2016-05-09 | STANDARD |
LABELING; Labeling | SUPPL | 63 | AP | 2017-03-10 | STANDARD |
LABELING; Labeling | SUPPL | 64 | AP | 2019-07-22 | STANDARD |
LABELING; Labeling | SUPPL | 65 | AP | 2021-04-28 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 25 | Null | 0 |
SUPPL | 26 | Null | 0 |
SUPPL | 28 | Null | 0 |
SUPPL | 33 | Null | 0 |
SUPPL | 42 | Null | 0 |
SUPPL | 43 | Null | 0 |
SUPPL | 45 | Null | 0 |
SUPPL | 47 | Null | 0 |
SUPPL | 48 | Null | 0 |
SUPPL | 52 | Null | 0 |
SUPPL | 53 | Null | 0 |
SUPPL | 54 | Null | 0 |
SUPPL | 61 | Null | 6 |
SUPPL | 62 | Null | 6 |
SUPPL | 63 | Null | 6 |
SUPPL | 64 | Null | 7 |
SUPPL | 65 | Null | 15 |
TE Codes
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"]
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[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
)
)