Isosorbide Dinitrate

ANDA 86033, held by Watson Labs. Isosorbide Dinitrate.

As of Nov 14, 2026, ANDA 86033 (Isosorbide Dinitrate), held by Watson Labs, was first approved by FDA on Feb 26, 1988, with 12 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1988
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Feb 26, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Isosorbide Dinitrate2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;sublingual	Isosorbide Dinitrate	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Dec 10, 1996	Supplement 30Labeling	Approved	None posted
Aug 25, 1992	Supplement 29Labeling	Approved	None posted
Apr 2, 1992	Supplement 28Labeling	Approved	None posted
Sep 12, 1991	Supplement 27Labeling	Approved	None posted
Aug 7, 1991	Supplement 25Manufacturing	Approved	None posted
Feb 13, 1991	Supplement 22Manufacturing	Approved	None posted
Feb 13, 1991	Supplement 24Manufacturing	Approved	None posted
Nov 19, 1990	Supplement 26Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 21Manufacturing	Approved	None posted
Jun 13, 1988	Supplement 20Labeling	Approved	None posted
Feb 26, 1988	Original application	Approved	None posted
Jun 17, 1985	Supplement 18Manufacturing	Approved	None posted
Feb 25, 1985	Supplement 16Manufacturing	Approved	None posted

Identifiers

Application: ANDA 86033
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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