Aralen Phosphate W/ Primaquine Phosphate

NDA 14860, held by Sanofi Aventis US. Chloroquine Phosphate; Primaquine Phosphate.

As of Nov 14, 2026, NDA 14860 (Aralen Phosphate W/ Primaquine Phosphate), held by Sanofi Aventis US, was first approved by FDA on Dec 9, 1968, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 9, 1968
Review: Priority
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 9, 1968	Original applicationNew combination · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aralen Phosphate W/ Primaquine PhosphateEQ 300MG BASE;EQ 45MG BASE · tablet;oral	Chloroquine Phosphate; Primaquine Phosphate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


May 29, 1990	Supplement 15Manufacturing · Priority review	Approved	None posted
Mar 3, 1987	Supplement 14Labeling · Priority review	Approved	None posted
Dec 4, 1986	Supplement 12Labeling · Priority review	Approved	None posted
Jan 26, 1984	Supplement 13Manufacturing · Priority review	Approved	None posted
May 15, 1981	Supplement 11Manufacturing · Priority review	Approved	None posted
May 15, 1981	Supplement 10Manufacturing · Priority review	Approved	None posted
Sep 9, 1976	Supplement 9Manufacturing · Priority review	Approved	None posted
Dec 9, 1968	Original applicationNew combination · Priority review	Approved	None posted

Identifiers

Application: NDA 14860
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