← FDA DRUG APPROVALS

FDA NDA · NDA008316

PRIMAQUINE PHOSPHATE

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA008316
TYPE
NDA
ORIGINAL APPROVAL
1952-01-23
LATEST ACTION
2026-02-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PRIMAQUINE · ReferencePrescription
PRIMAQUINE PHOSPHATE EQ 15MG BASE · TABLET · ORAL

Approval history

2026-02-02Labeling · Supplement 26 · standard — Label ↗AP
2025-03-10Labeling · Supplement 25 · standard — Label ↗AP
2017-06-22Labeling · Supplement 23 · standard — Letter ↗AP
2016-07-27Labeling · Supplement 22 · standard — Letter ↗AP
2015-04-16Labeling · Supplement 21 · standard — Letter ↗AP
2008-07-28Labeling · Supplement 17 · standard — Letter ↗AP
2003-06-11Labeling · Supplement 15 · standard — Letter ↗AP
1993-10-27Manufacturing (CMC) · Supplement 14 · standardAP
1993-09-23Manufacturing (CMC) · Supplement 13 · standardAP
1990-05-29Manufacturing (CMC) · Supplement 11 · standardAP
1986-11-10Labeling · Supplement 7AP
1985-10-28Manufacturing (CMC) · Supplement 10 · standardAP
1985-09-10Labeling · Supplement 9AP
1984-10-30Manufacturing (CMC) · Supplement 8 · standardAP
1981-05-15Manufacturing (CMC) · Supplement 6 · standardAP
1977-02-07Labeling · Supplement 5AP
1976-09-11Manufacturing (CMC) · Supplement 4 · standardAP
1952-01-23Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →