Chlorthalidone

ANDA 87312, held by Kv Pharm. Chlorthalidone.

As of Nov 15, 2026, ANDA 87312 (Chlorthalidone), held by Kv Pharm, was first approved by FDA on Mar 11, 1981, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 11, 1981
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 11, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorthalidone50MG · tablet;oral	Chlorthalidone	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jul 9, 1984	Supplement 6Manufacturing	Approved	None posted
Mar 24, 1983	Supplement 5Manufacturing	Approved	None posted
Mar 11, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87312
Drugs@FDA: Overview at FDA
Company: KV Pharmaceutical

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