FDA.reportPublic FDA data

Application 017581

Type
NDA
Sponsor
ATNAHS PHARMA US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NAPROSYNNAPROXENTABLET;ORAL250MGYesNo
003NAPROSYNNAPROXENTABLET;ORAL375MGYesNo
004NAPROSYNNAPROXENTABLET;ORAL500MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42494-403NAPROXENnaproxenCameron Pharmaceuticals, LLCNDACurrent
42494-404NAPROXENnaproxenCameron Pharmaceuticals, LLCNDACurrent
42494-405NAPROXENnaproxenCameron Pharmaceuticals, LLCNDACurrent
69437-316NaprosynnaproxenCanton LaboratoriesNDACurrent
69437-316NaprosynnaproxenCanton LaboratoriesNDACurrent
69437-316NaprosynnaproxenCanton LaboratoriesNDACurrent
69437-316NaprosynnaproxenCanton LaboratoriesNDACurrent
69784-505NAPROXENnaproxenWoodward Pharma Services LLCNDACurrent
69784-505NAPROXENnaproxenWoodward Pharma Services LLCNDACurrent
69784-505NAPROXENnaproxenWoodward Pharma Services LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80351SUPPL 2024-11-25
80291SUPPL 2024-11-22
80290SUPPL 2024-11-22
78456SUPPL 2024-05-14
78455SUPPL 2024-05-14
67236SUPPL2021-04-29
67233SUPPL2021-04-29
67232SUPPL2021-04-29
59427SUPPL2019-07-23
59426SUPPL2019-07-23
59414SUPPL2019-07-23
47557SUPPL2017-03-14
47539SUPPL2017-03-13
33313SUPPL2016-05-11
654SUPPL2016-05-11
33312SUPPL2013-03-26
653SUPPL2013-03-26
13863SUPPL2008-07-30
11039SUPPL2008-07-29
11038SUPPL2007-09-26
652SUPPL2007-09-25
13862SUPPL2007-04-25
40753SUPPL2007-04-11
13860SUPPL2006-03-23
11036SUPPL2006-03-14
13861SUPPL2006-01-30
11037SUPPL2006-01-25
33311SUPPL2004-11-16
13859SUPPL2004-11-16
11035SUPPL2004-11-16
651SUPPL2004-11-16
650SUPPL2003-05-29