Hydrochlorothiazide

ANDA 77885, held by Hikma. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 77885 (Hydrochlorothiazide), held by Hikma, was first approved by FDA on Nov 26, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 26, 2007
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
Nov 26, 2007	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide12.5MG · capsule;oral	Hydrochlorothiazide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 4, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Aug 17, 2011	Supplement 1Labeling	Approved	None posted
Nov 26, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77885
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