Chloroquine Phosphate

ANDA 83082, held by Hikma. Chloroquine Phosphate.

As of Nov 15, 2026, ANDA 83082 (Chloroquine Phosphate), held by Hikma, was first approved by FDA on Jul 9, 1975, with 29 approved supplements and 0 published complete response letters.

First approved: Jul 9, 1975
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Jul 9, 1975	Original application	Approved	None posted

Products

2 strengths and forms


Chloroquine Phosphate250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Chloroquine Phosphate	Discontinued
Chloroquine Phosphate500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Chloroquine Phosphate	Discontinued

All 30 submissions, including labeling and manufacturing supplements


Jul 24, 2023	Supplement 59Labeling · Standard review	Approved	None posted
May 3, 2022	Supplement 58Labeling · Standard review	Approved	None posted
Mar 17, 2022	Supplement 57Labeling · Standard review	Approved	None posted
May 29, 2020	Supplement 56Labeling · Standard review	Approved	None posted
Nov 10, 2009	Supplement 50Labeling	Approved	Label
May 31, 2007	Supplement 49Labeling	Approved	None posted
Mar 21, 2006	Supplement 48Labeling	Approved	None posted
Sep 29, 2005	Supplement 47Labeling	Approved	None posted
Jul 11, 2001	Supplement 41Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 40Labeling	Approved	None posted
Nov 30, 2000	Supplement 39Manufacturing	Approved	None posted
Nov 30, 2000	Supplement 38Manufacturing	Approved	None posted
May 24, 2000	Supplement 37Manufacturing	Approved	None posted
May 24, 2000	Supplement 36Manufacturing	Approved	None posted
May 24, 2000	Supplement 35Labeling	Approved	None posted
May 24, 2000	Supplement 31Manufacturing	Approved	None posted
May 24, 2000	Supplement 30Labeling	Approved	None posted
May 24, 2000	Supplement 29Manufacturing	Approved	None posted
Sep 17, 1999	Supplement 34Manufacturing	Approved	None posted
Sep 17, 1999	Supplement 33Labeling	Approved	None posted
Sep 17, 1999	Supplement 32Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 28Manufacturing	Approved	None posted
Sep 5, 1997	Supplement 27Manufacturing	Approved	None posted
Sep 5, 1997	Supplement 26Manufacturing	Approved	None posted
Sep 5, 1997	Supplement 25Manufacturing	Approved	None posted
Sep 5, 1997	Supplement 24Manufacturing	Approved	None posted
Sep 5, 1997	Supplement 23Manufacturing	Approved	None posted
Apr 2, 1991	Supplement 22Manufacturing	Approved	None posted
Jul 20, 1989	Supplement 21Bioequivalence	Approved	None posted
Jul 9, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 83082
Drugs@FDA: Overview at FDA
Company: Hikma

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