Isordil

Prevents angina pectoris due to coronary artery disease. NDA 12093, held by Bausch. Isosorbide Dinitrate.

As of Nov 13, 2026, NDA 12093 (Isordil), held by Bausch, was first approved by FDA on Nov 9, 1959, with 8 approved supplements and 0 published complete response letters.

First approved: Nov 9, 1959
Review: Priority
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Isosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Nov 9, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

5 strengths and forms


Isordil40MG · tablet;oral	Isosorbide Dinitrate	RxReference drug
Isordil10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Isosorbide Dinitrate	DiscontinuedReference drug
Isordil30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Isosorbide Dinitrate	DiscontinuedReference drug
Isordil20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Isosorbide Dinitrate	DiscontinuedReference drug
Isordil5MG · tablet;oral	Isosorbide Dinitrate	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Jan 14, 2015	Supplement 52Labeling · Standard review	Approved	Letter Label
Nov 20, 2014	Supplement 51Manufacturing	Approved	None posted
Sep 26, 2001	Supplement 44Labeling · Standard review	Approved	Letter
Jun 16, 1999	Supplement 43Labeling · Standard review	Approved	None posted
Jan 11, 1995	Supplement 41Labeling	Approved	None posted
Oct 16, 1991	Supplement 42Manufacturing	Approved	None posted
Feb 16, 1989	Supplement 34Manufacturing	Approved	None posted
Jul 29, 1988	Supplement 37Labeling	Approved	None posted
Nov 9, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12093
Drugs@FDA: Overview at FDA
Company: Bausch Health

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