Chloroquine Phosphate

ANDA 90249, held by Ipca Labs Ltd. Chloroquine Phosphate.

As of Nov 15, 2026, ANDA 90249 (Chloroquine Phosphate), held by Ipca Labs Ltd, was first approved by FDA on Dec 3, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 3, 2009
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 3, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chloroquine Phosphate500MG · tablet;oral	Chloroquine Phosphate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jul 24, 2023	Supplement 8Labeling · Standard review	Approved	None posted
May 3, 2022	Supplement 7Labeling · Standard review	Approved	None posted
Mar 17, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Mar 24, 2020	Supplement 3Labeling · Standard review	Approved	Letter
Mar 24, 2020	Supplement 4Labeling · Standard review	Approved	Letter
Aug 28, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Dec 3, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90249
Drugs@FDA: Overview at FDA
Company: Ipca 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