FDA.reportPublic FDA data

Application 021519

Type
NDA
Sponsor
ANI PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUVOXFLUVOXAMINE MALEATETABLET;ORAL25MGNoNo
002LUVOXFLUVOXAMINE MALEATETABLET;ORAL50MGNoNo
003LUVOXFLUVOXAMINE MALEATETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-683fluvoxamine maleateFluvoxamine maleateAidarex Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
49349-991FLuvoxamine MaleateFLUVOXAMINE MALEATEREMEDYREPACK INC.NDACurrent
50090-5988fluvoxamine maleateFluvoxamine maleateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
62559-158fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-158fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-158fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-158fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-159fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-159fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-159fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-159fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-160fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-160fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-160fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
62559-160fluvoxamine maleateFluvoxamine maleateANI Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
63629-8018fluvoxamine maleateFluvoxamine maleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8018fluvoxamine maleateFluvoxamine maleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68071-2337fluvoxamine maleateFluvoxamine maleateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68151-0637fluvoxamine maleateFluvoxamine maleateCarilion Materials ManagementNDA AUTHORIZED GENERICCurrent
68788-7219fluvoxamine maleateFluvoxamine maleatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7219fluvoxamine maleateFluvoxamine maleatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7219fluvoxamine maleateFluvoxamine maleatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7219fluvoxamine maleateFluvoxamine maleatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
68788-7219fluvoxamine maleateFluvoxamine maleatePreferred Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
70518-1057fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1057fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1057fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1057fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1057fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1057fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1643fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1643fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1643fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1643fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1789fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1789fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1789fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1789fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
71335-0264fluvoxamine maleateFluvoxamine maleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0264fluvoxamine maleateFluvoxamine maleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0264fluvoxamine maleateFluvoxamine maleateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75251SUPPL 2023-08-22
75250SUPPL 2023-08-22
75229SUPPL 2023-08-22
73110SUPPL2023-01-06
68729SUPPL2021-09-23
68713SUPPL2021-09-21
68712SUPPL2021-09-21
61334SUPPL2019-12-19
61314SUPPL2019-12-17
61313SUPPL2019-12-17
46748SUPPL2017-01-10
46747SUPPL2017-01-10
46693SUPPL2017-01-06
37134SUPPL2014-07-29
5612SUPPL2014-07-23
28012SUPPL2012-12-03
15666SUPPL2012-12-03
44133ORIG2012-02-13
15665SUPPL2011-03-21
5611SUPPL2011-03-21
15664SUPPL2009-03-17
5610SUPPL2009-02-27
24203ORIG2008-11-10
21711ORIG2008-11-10
28011ORIG2008-01-09
37133ORIG2007-12-27