Oretic

NDA 11971, held by Abbvie. Hydrochlorothiazide.

As of Nov 14, 2026, NDA 11971 (Oretic), held by Abbvie, was first approved by FDA on Jul 6, 1959, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 6, 1959
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jul 6, 1959	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Oretic25MG · tablet;oral	Hydrochlorothiazide	Discontinued
Oretic50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Apr 16, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Sep 13, 1991	Supplement 21Labeling · Standard review	Approved	None posted
Jul 15, 1985	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 15, 1983	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 11, 1982	Supplement 22Manufacturing · Standard review	Approved	None posted
May 14, 1982	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 29, 1976	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 3, 1976	Supplement 15Labeling · Standard review	Approved	None posted
Mar 3, 1975	Supplement 12Labeling · Standard review	Approved	None posted
Jul 6, 1959	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 11971
Drugs@FDA: Overview at FDA
Company: AbbVie

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