Primaquine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-04-30)
Oldest Current Product
2010-01-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\PRIMAQUINE
FDAOB
ORAL\TABLET\PRIMAQUINE PHOSPHATE
SPL Active
ORAL\TABLET, FILM COATED\PRIMAQUINE PHOSPHATE
ORAL\TABLET\PRIMAQUINE PHOSPHATE
SPL Moiety
ORAL\TABLET, FILM COATED\PRIMAQUINE
ORAL\TABLET\PRIMAQUINE

product(s) by strength(s)

primaquine phosphate 26.3 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000241596NDASanofi-Aventis U.S. Llc2011-04-15PRIMAQUINE PHOSPHATEORALTABLET, FILM COATEDNDA0083161bfbf4ae-81b8-4160-a00d-6322aadd4b59

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810331ANDAAlvogen, Inc.2011-12-08PRIMAQUINE PHOSPHATEORALTABLET, FILM COATEDANDA203924a64d2ff5-7d0e-472e-5168-91f304a8c750
2763850102ANDABayshore Pharmaceuticals Llc2014-08-01PRIMAQUINE PHOSPHATEORALTABLETANDA2044760c8c2bc6-428b-40b6-8114-6df80290878d

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1430630225NDAPd-Rx Pharmaceuticals, Inc.2010-01-01PRIMAQUINE PHOSPHATEORALTABLET000241596NDA008316222f3d0a-7649-44ad-99b2-b2dc8c298e7b
2604290035ANDAGolden State Medical Supply, Inc.2014-05-08PRIMAQUINE PHOSPHATEORALTABLET, FILM COATED763850102ANDA2044764933e6d9-0e9e-415f-8325-25212c6fe297

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA203924PRIMAQUINE PHOSPHATEALVOGEN INC2014-02-03ANDA203924_001
2ANDA204476PRIMAQUINE PHOSPHATEBAYSHORE PHARMACEUTICALS LLC2014-02-25ANDA204476_001
3NDA008316PRIMAQUINESANOFI AVENTIS US LLCNDA008316_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203924_001RXPRIMAQUINE PHOSPHATE (EQ 15MG BASE)ORALTABLETFalseAB2014-02-03PRIMAQUINE PHOSPHATE
2ANDA204476_001RXPRIMAQUINE PHOSPHATE (EQ 15MG BASE)ORALTABLETFalseAB2014-02-25PRIMAQUINE PHOSPHATE
3NDA008316_001RXPRIMAQUINE PHOSPHATE (EQ 15MG BASE)ORALTABLETTrueABPRIMAQUINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10c8c2bc6-428b-40b6-8114-6df80290878d (view SPL)PRIMAQUINE PHOSPHATE TABLETS, USPprescriptionHuman PrescriptionBayshore Pharmaceuticals Llcmanufacture2015-10-232763850102
21bfbf4ae-81b8-4160-a00d-6322aadd4b59 (view SPL)PRIMAQUINE PHOSPHATE TABLETS, USPprescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-04-309000241596
3222f3d0a-7649-44ad-99b2-b2dc8c298e7b (view SPL)PRIMAQUINEPHOSPHATETABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2008-10-161430630225
44933e6d9-0e9e-415f-8325-25212c6fe297 (view SPL)Primaquine Phosphate Tablets, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-12-313604290035
5a64d2ff5-7d0e-472e-5168-91f304a8c750 (view SPL)prescriptionHuman PrescriptionAlvogen, Inc.analysis, label, manufacture, pack2012-05-304477810331

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII