Primaquine Phosphate

ANDA 206043, held by Ingenus Pharms LLC. Primaquine Phosphate.

As of Nov 15, 2026, ANDA 206043 (Primaquine Phosphate), held by Ingenus Pharms LLC, was first approved by FDA on Jun 23, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 23, 2016
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Primaquine phosphate tablets are indicated for the radical cure (prevention of relapse) of vivax malaria.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 23, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Primaquine PhosphateEQ 15MG BASE · tablet;oral	Primaquine Phosphate	Rx

All 5 submissions, including labeling and manufacturing supplements


May 7, 2026	Supplement 6Labeling · Standard review	Approved	None posted
May 7, 2026	Supplement 5Labeling · Standard review	Approved	None posted
Jun 12, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Jun 12, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Jun 23, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206043
Drugs@FDA: Overview at FDA
Company: Ingenus Pharmaceuticals

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