Dutoprol

NDA 21956, held by Concordia. Hydrochlorothiazide; Metoprolol Succinate.

As of Nov 14, 2026, NDA 21956 (Dutoprol), held by Concordia, was first approved by FDA on Aug 28, 2006, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2006
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
Aug 28, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Dutoprol12.5MG;EQ 25MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Hydrochlorothiazide; Metoprolol Succinate	DiscontinuedReference drug
Dutoprol12.5MG;EQ 50MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Hydrochlorothiazide; Metoprolol Succinate	DiscontinuedReference drug
Dutoprol12.5MG;EQ 100MG TARTRATE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet, extended release;oral	Hydrochlorothiazide; Metoprolol Succinate	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Jan 14, 2022	Supplement 11Labeling · Standard review	Approved	Letter Label
Aug 20, 2020	Supplement 12Labeling · Standard review	Approved	Label Letter
Aug 16, 2017	Supplement 10Labeling · Standard review	Approved	Letter Label
Jun 6, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 2, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 20, 2014	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 19, 2011	Supplement 3Labeling	Approved	Letter Label
Mar 2, 2011	Supplement 1Labeling	Approved	Letter Label
Mar 2, 2011	Supplement 2Labeling	Approved	Letter Label
Aug 28, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21956
Drugs@FDA: Overview at FDA
Company: Concordia Pharmaceuticals

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