Primaquine Phosphate

ANDA 204476, held by Unichem. Primaquine Phosphate.

As of Nov 15, 2026, ANDA 204476 (Primaquine Phosphate), held by Unichem, was first approved by FDA on Feb 25, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 25, 2014
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
Feb 25, 2014	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


Sep 14, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Aug 18, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Feb 27, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Feb 27, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Feb 25, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 204476
Drugs@FDA: Overview at FDA
Company: Unichem Laboratories

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