FDA.reportPublic FDA data

Application 018965

Type
NDA
Sponsor
ATNAHS PHARMA US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROSYNNAPROXENSUSPENSION;ORAL25MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0899NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-0899NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-0899NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-1798NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-1798NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-1798NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-2697NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-2697NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
0121-2697NaprosynNaproxenPharmaceutical Associates, Inc.NDACurrent
42192-619NaproxenNaproxenAcella Pharmaceuticals, LLCNDACurrent
70868-200NaproxenNaproxenKey Therapeutics, LLCNDACurrent
71297-200NaproxenNaproxenAllegis Holdings, LLCNDACurrent
71297-200NaproxenNaproxenAllegis Holdings, LLCNDACurrent
71511-701NaprosynNaproxenAthena BioscienceNDACurrent
71511-701NaprosynNaproxenAthena Bioscience, LLCNDACurrent
71511-701NaprosynNaproxenAthena BioscienceNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80345SUPPL 2024-11-25
80322SUPPL 2024-11-22
80321SUPPL 2024-11-22
67310SUPPL2021-04-30
67309SUPPL2021-04-30
67247SUPPL2021-04-29
59425SUPPL2019-07-23
59409SUPPL2019-07-23
47562SUPPL2017-03-14
47542SUPPL2017-03-13
47541SUPPL2017-03-13
16141SUPPL2016-05-12
1159SUPPL2016-05-12
33675SUPPL2016-05-11
11391SUPPL2016-05-11
16140SUPPL2013-03-26
11390SUPPL2013-03-26
1158SUPPL2008-07-30
11389SUPPL2008-07-29
11388SUPPL2007-09-26
1157SUPPL2007-09-25
16139SUPPL2007-04-25
16137SUPPL2006-03-23
11386SUPPL2006-03-14
16138SUPPL2006-01-30
11387SUPPL2006-01-25
33674SUPPL2004-11-16
11385SUPPL2004-11-16
1156SUPPL2004-11-16
1155SUPPL2004-11-16
16136SUPPL2003-05-29