Chloroquine Phosphate

Treats uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P.…. ANDA 80880, held by Impax Labs. Chloroquine Phosphate.

As of Nov 15, 2026, ANDA 80880 (Chloroquine Phosphate), held by Impax Labs, was first approved by FDA on Dec 11, 1974, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 11, 1974
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Chloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax. Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present. Treatment of extraintestinal amebiasis. Chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites. Limitations of Use in Malaria: Do not use chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Dec 11, 1974	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chloroquine Phosphate250MG · tablet;oral	Chloroquine Phosphate	Rx

All 11 submissions, including labeling and manufacturing supplements


Oct 14, 2026	Supplement 70Labeling · Standard review	Approved	None posted
Feb 2, 2024	Supplement 69Labeling · Standard review	Approved	None posted
Jul 24, 2023	Supplement 68Labeling · Standard review	Approved	None posted
May 3, 2022	Supplement 66Labeling · Standard review	Approved	None posted
Mar 17, 2022	Supplement 65Labeling · Standard review	Approved	None posted
Apr 30, 2020	Supplement 63Labeling · Standard review	Approved	None posted
Jul 18, 1997	Supplement 45Manufacturing	Approved	None posted
Oct 11, 1996	Supplement 43Labeling	Approved	None posted
Dec 15, 1988	Supplement 40Labeling	Approved	None posted
Nov 22, 1988	Supplement 39Labeling	Approved	None posted
Dec 11, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 80880
Drugs@FDA: Overview at FDA
Company: Impax 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