Chloroquine Phosphate

ANDA 87979, held by Watson Labs. Chloroquine Phosphate.

As of Nov 15, 2026, ANDA 87979 (Chloroquine Phosphate), held by Watson Labs, was first approved by FDA on Dec 21, 1982, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1982
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 21, 1982	Original application	Approved	None posted

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Oct 20, 1994	Supplement 14Labeling	Approved	None posted
Oct 27, 1993	Supplement 12Manufacturing	Approved	None posted
Sep 23, 1993	Supplement 13Labeling	Approved	None posted
May 31, 1991	Supplement 10Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 11Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 9Manufacturing	Approved	None posted
Sep 7, 1989	Supplement 8Labeling	Approved	None posted
Jan 3, 1989	Supplement 6Manufacturing	Approved	None posted
Jan 3, 1989	Supplement 7Manufacturing	Approved	None posted
Dec 30, 1988	Supplement 5Bioequivalence	Approved	None posted
Dec 3, 1985	Supplement 2Manufacturing	Approved	None posted
Dec 3, 1985	Supplement 3Manufacturing	Approved	None posted
Jun 17, 1985	Supplement 1Manufacturing	Approved	None posted
Dec 21, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87979
Drugs@FDA: Overview at FDA
Company: Watson 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