Sorbitrate

NDA 16192, held by Astrazeneca. Isosorbide Dinitrate.

As of Nov 14, 2026, NDA 16192 (Sorbitrate), held by Astrazeneca, was first approved by FDA on Jan 16, 1968, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 16, 1968
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 16, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Sorbitrate5MG · tablet;oral	Isosorbide Dinitrate	Discontinued
Sorbitrate10MG · tablet;oral	Isosorbide Dinitrate	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jan 26, 1999	Supplement 43Labeling · Standard review	Approved	None posted
Oct 11, 1996	Supplement 42Manufacturing · Standard review	Approved	None posted
Apr 1, 1996	Supplement 41Manufacturing · Standard review	Approved	None posted
Jul 9, 1981	Supplement 25Labeling · Standard review	Approved	None posted
Aug 5, 1980	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 16, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16192
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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