FDA.reportPublic FDA data

Application 008316

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMAQUINEPRIMAQUINE PHOSPHATETABLET;ORALEQ 15MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-1596Primaquine PhosphatePrimaquine PhosphateSanofi-Aventis U.S. LLCNDACurrent
0024-1596Primaquine PhosphatePrimaquine PhosphateSanofi-Aventis U.S. LLCNDACurrent
0024-1596Primaquine PhosphatePrimaquine PhosphateSanofi-Aventis U.S. LLCNDACurrent
0024-1596Primaquine PhosphatePrimaquine Phosphatesanofi-aventis U.S. LLCNDACurrent
43063-225Primaquine PhosphatePrimaquine PhosphatePD-Rx Pharmaceuticals, InNDACurrent
43063-225Primaquine PhosphatePrimaquine PhosphatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-225Primaquine PhosphatePrimaquine PhosphatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-225Primaquine PhosphatePrimaquine PhosphatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-225Primaquine PhosphatePrimaquine PhosphatePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-225Primaquine PhosphatePrimaquine PhosphatePD-Rx Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84900SUPPL 2026-02-03
81537SUPPL 2025-03-12
81536SUPPL 2025-03-11
48831SUPPL2017-06-26
48826SUPPL2017-06-26
96SUPPL2016-07-29
32961SUPPL2016-07-28
10700SUPPL2015-04-17
95SUPPL2015-04-17
32960SUPPL2008-08-13
94SUPPL2008-08-13
10699SUPPL2003-06-22
93SUPPL2003-06-22