Combipres

NDA 17503, held by Boehringer Ingelheim. Chlorthalidone; Clonidine Hydrochloride.

As of Nov 14, 2026, NDA 17503 (Combipres), held by Boehringer Ingelheim, was first approved by FDA on Sep 3, 1974, with 27 approved supplements and 0 published complete response letters.

First approved: Sep 3, 1974
Review: Priority
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Sep 3, 1974	Original applicationNew molecular entity, new combination · Priority review	Approved	None posted

Products

3 strengths and forms


Combipres15MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Chlorthalidone; Clonidine Hydrochloride	DiscontinuedReference drug
Combipres15MG;0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Chlorthalidone; Clonidine Hydrochloride	DiscontinuedReference drug
Combipres15MG;0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Chlorthalidone; Clonidine Hydrochloride	DiscontinuedReference drug

All 28 submissions, including labeling and manufacturing supplements


Sep 15, 1999	Supplement 28Manufacturing · Priority review	Approved	None posted
Apr 8, 1991	Supplement 27Manufacturing · Priority review	Approved	None posted
Feb 20, 1991	Supplement 26Labeling · Priority review	Approved	None posted
Aug 7, 1987	Supplement 25Manufacturing · Priority review	Approved	None posted
Mar 26, 1987	Supplement 24Labeling · Priority review	Approved	None posted
Apr 10, 1986	Supplement 23Labeling · Priority review	Approved	None posted
Oct 2, 1985	Supplement 22Labeling · Priority review	Approved	None posted
Feb 25, 1985	Supplement 20Manufacturing · Priority review	Approved	None posted
Dec 18, 1984	Supplement 21Manufacturing · Priority review	Approved	None posted
Nov 19, 1984	Supplement 19Manufacturing · Priority review	Approved	None posted
Aug 1, 1984	Supplement 18Manufacturing · Priority review	Approved	None posted
Apr 10, 1984	Supplement 17Labeling · Priority review	Approved	None posted
Mar 9, 1983	Supplement 16Manufacturing · Priority review	Approved	None posted
Jul 31, 1981	Supplement 15Manufacturing · Priority review	Approved	None posted
Apr 9, 1981	Supplement 14Manufacturing · Priority review	Approved	None posted
Feb 5, 1981	Supplement 5Manufacturing · Priority review	Approved	None posted
Jan 15, 1981	Supplement 12Manufacturing · Priority review	Approved	None posted
Nov 28, 1980	Supplement 13Manufacturing · Priority review	Approved	None posted
Nov 28, 1980	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 28, 1980	Supplement 10Manufacturing · Priority review	Approved	None posted
Feb 26, 1980	Supplement 9Manufacturing · Priority review	Approved	None posted
Feb 26, 1980	Supplement 8Manufacturing · Priority review	Approved	None posted
Jan 31, 1979	Supplement 7Manufacturing · Priority review	Approved	None posted
Jan 17, 1977	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 10, 1976	Supplement 4Manufacturing · Priority review	Approved	None posted
Jul 9, 1976	Supplement 2Manufacturing · Priority review	Approved	None posted
Jun 8, 1976	Supplement 1Manufacturing · Priority review	Approved	None posted
Sep 3, 1974	Original applicationNew molecular entity, new combination · Priority review	Approved	None posted

Identifiers

Application: NDA 17503
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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