Primaquine

NDA 8316, held by Sanofi Aventis US. Primaquine Phosphate.

As of Nov 13, 2026, NDA 8316 (Primaquine), held by Sanofi Aventis US, was first approved by FDA on Jan 23, 1952, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 23, 1952
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 23, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PrimaquineEQ 15MG BASE · tablet;oral	Primaquine Phosphate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


Feb 2, 2026	Supplement 26Labeling · Standard review	Approved	Label
Mar 10, 2025	Supplement 25Labeling · Standard review	Approved	Letter Label
Jun 22, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 27, 2016	Supplement 22Labeling · Standard review	Approved	Letter Label
Apr 16, 2015	Supplement 21Labeling · Standard review	Approved	Letter Label
Jul 28, 2008	Supplement 17Labeling · Standard review	Approved	Letter Label
Jun 11, 2003	Supplement 15Labeling · Standard review	Approved	Letter Label
Oct 27, 1993	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 23, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
May 29, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 10, 1986	Supplement 7Labeling	Approved	None posted
Oct 28, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Sep 10, 1985	Supplement 9Labeling	Approved	None posted
Oct 30, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
May 15, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 7, 1977	Supplement 5Labeling	Approved	None posted
Sep 11, 1976	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 23, 1952	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 8316
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters