Isosorbide Dinitrate

Prevents angina pectoris due to coronary artery disease. ANDA 86925, held by Ph Health. Isosorbide Dinitrate.

As of Nov 13, 2026, ANDA 86925 (Isosorbide Dinitrate), held by Ph Health, was first approved by FDA on Mar 12, 1987, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 12, 1987
Supplements approved: 16
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 17 submissions below

Date	Submission	Status	Documents
Mar 12, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isosorbide Dinitrate10MG · tablet;oral	Isosorbide Dinitrate	Rx

All 17 submissions, including labeling and manufacturing supplements


Jan 8, 2025	Supplement 41Labeling · Standard review	Approved	None posted
May 24, 2002	Supplement 37Labeling	Approved	None posted
Dec 7, 1999	Supplement 36Labeling	Approved	None posted
Mar 9, 1998	Supplement 35Manufacturing	Approved	None posted
Jun 23, 1997	Supplement 34Labeling	Approved	None posted
Jul 11, 1996	Supplement 33Labeling	Approved	None posted
Mar 16, 1994	Supplement 29Manufacturing	Approved	None posted
Mar 16, 1994	Supplement 28Manufacturing	Approved	None posted
Nov 1, 1991	Supplement 32Labeling	Approved	None posted
Mar 12, 1987	Original application	Approved	None posted
Mar 29, 1985	Supplement 19Manufacturing	Approved	None posted
Dec 4, 1984	Supplement 21Manufacturing	Approved	None posted
Jul 27, 1983	Supplement 18Manufacturing	Approved	None posted
Jul 27, 1983	Supplement 16Manufacturing	Approved	None posted
Jul 27, 1983	Supplement 15Manufacturing	Approved	None posted
Sep 28, 1982	Supplement 12Manufacturing	Approved	None posted
Sep 28, 1982	Supplement 10Manufacturing	Approved	None posted

Identifiers

Application: ANDA 86925
Drugs@FDA: Overview at FDA
Company: PH 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