Isordil

NDA 12882, held by Wyeth Ayerst. Isosorbide Dinitrate.

As of Nov 13, 2026, NDA 12882 (Isordil), held by Wyeth Ayerst, was not approved, with 7 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 7
Complete response letters: 0

Products

2 strengths and forms


Isordil40MG · tablet, extended release;oral	Isosorbide Dinitrate	Discontinued
Isordil40MG · capsule, extended release;oral	Isosorbide Dinitrate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Jan 11, 1995	Supplement 32Labeling · Standard review	Approved	None posted
Oct 16, 1991	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 10, 1989	Supplement 33Manufacturing · Standard review	Approved	None posted
Jun 16, 1989	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 16, 1989	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 29, 1988	Supplement 26Labeling · Standard review	Approved	None posted
Dec 12, 1980	Supplement 15Manufacturing · Standard review	Approved	None posted

Identifiers

Application: NDA 12882
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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