FDA.reportPublic FDA data

Application 018164

Type
NDA
Sponsor
ATNAHS PHARMA US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANAPROXNAPROXEN SODIUMTABLET;ORALEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ANAPROX DSNAPROXEN SODIUMTABLET;ORALEQ 500MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42494-400NAPROXEN SODIUM DSnaproxen sodiumCameron Pharmaceuticals, LLCNDACurrent
42494-402NAPROXEN SODIUMnaproxen sodiumCameron Pharmaceuticals, LLCNDACurrent
69437-203Anaprox DSnaproxen sodiumCanton LaboratoriesNDACurrent
69437-203Anaprox DSnaproxen sodiumCanton LaboratoriesNDACurrent
69437-203Anaprox DSnaproxen sodiumCanton LaboratoriesNDACurrent
69437-203Anaprox DSnaproxen sodiumCanton LaboratoriesNDACurrent
69784-550NAPROXEN SODIUM DSnaproxen sodiumWoodward Pharma Services LLCNDACurrent
69784-550NAPROXEN SODIUM DSnaproxen sodiumWoodward Pharma Services LLCNDACurrent
69784-550NAPROXEN SODIUM DSnaproxen sodiumWoodward Pharma Services LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80352SUPPL 2024-11-25
80293SUPPL 2024-11-22
80292SUPPL 2024-11-22
78459SUPPL 2024-05-14
78458SUPPL 2024-05-14
67281SUPPL2021-04-30
67280SUPPL2021-04-30
67237SUPPL2021-04-29
59429SUPPL2019-07-23
59428SUPPL2019-07-23
59415SUPPL2019-07-23
47560SUPPL2017-03-14
47537SUPPL2017-03-13
14941SUPPL2016-05-11
11178SUPPL2016-05-11
14940SUPPL2013-03-26
11177SUPPL2013-03-26
869SUPPL2008-07-30
11176SUPPL2008-07-29
33454SUPPL2007-09-26
868SUPPL2007-09-25
14939SUPPL2007-04-25
867SUPPL2006-03-23
33452SUPPL2006-03-14
14938SUPPL2006-01-30
33453SUPPL2006-01-25
44021ORIG2005-07-28
33451SUPPL2004-11-16
33450SUPPL2004-11-16
866SUPPL2004-11-16
865SUPPL2004-11-16
864SUPPL2003-05-29