Dilatrate-Sr

NDA 19790, held by Endo Operations. Isosorbide Dinitrate.

As of Nov 14, 2026, NDA 19790 (Dilatrate-Sr), held by Endo Operations, was first approved by FDA on Sep 2, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 2, 1988
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Sep 2, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dilatrate-Sr40MG · capsule, extended release;oral	Isosorbide Dinitrate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Oct 24, 2014	Supplement 11Labeling · Standard review	Approved	Label Letter
Jan 30, 2002	Supplement 9Labeling · Standard review	Approved	None posted
Oct 29, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Jan 13, 1999	Supplement 7Labeling · Standard review	Approved	None posted
Jul 9, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
May 31, 1996	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 13, 1996	Supplement 3Labeling	Approved	None posted
Mar 12, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 9, 1991	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 20, 1991	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 2, 1988	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 19790
Drugs@FDA: Overview at FDA
Company: Endo Operations

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