Home Applications 008316 Application 008316
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRIMAQUINE PRIMAQUINE PHOSPHATE TABLET;ORAL EQ 15MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N008316-001 PRIMAQUINE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N008316-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N008316-001 PRIMAQUINE EQ 15MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N008316-001 PRIMAQUINE EQ 15MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N008316-001 PRIMAQUINE EQ 15MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N008316-001 PRIMAQUINE EQ 15MG BASE TABLET / ORAL AB RLD, RS, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0024-1596 Primaquine Phosphate Primaquine Phosphate Sanofi-Aventis U.S. LLC NDA Current 0024-1596 Primaquine Phosphate Primaquine Phosphate Sanofi-Aventis U.S. LLC NDA Current 0024-1596 Primaquine Phosphate Primaquine Phosphate Sanofi-Aventis U.S. LLC NDA Current 0024-1596 Primaquine Phosphate Primaquine Phosphate sanofi-aventis U.S. LLC NDA Current 43063-225 Primaquine Phosphate Primaquine Phosphate PD-Rx Pharmaceuticals, In NDA Current 43063-225 Primaquine Phosphate Primaquine Phosphate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-225 Primaquine Phosphate Primaquine Phosphate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-225 Primaquine Phosphate Primaquine Phosphate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-225 Primaquine Phosphate Primaquine Phosphate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-225 Primaquine Phosphate Primaquine Phosphate PD-Rx Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84900 SUPPL 2026-02-03 81537 SUPPL 2025-03-12 81536 SUPPL 2025-03-11 48831 SUPPL 2017-06-26 48826 SUPPL 2017-06-26 96 SUPPL 2016-07-29 32961 SUPPL 2016-07-28 10700 SUPPL 2015-04-17 95 SUPPL 2015-04-17 32960 SUPPL 2008-08-13 94 SUPPL 2008-08-13 10699 SUPPL 2003-06-22 93 SUPPL 2003-06-22