Isuprel

NDA 6328, held by Sanofi Aventis US. Isoproterenol Hydrochloride.

As of Nov 13, 2026, NDA 6328 (Isuprel), held by Sanofi Aventis US, was first approved by FDA on Feb 19, 1948, with 9 approved supplements and 0 published complete response letters.

First approved: Feb 19, 1948
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Feb 19, 1948	Original application	Approved	None posted

Products

2 strengths and forms


Isuprel10MG · tablet;rectal, sublingual	Isoproterenol Hydrochloride	Discontinued
Isuprel15MG · tablet;rectal, sublingual	Isoproterenol Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


May 12, 1998	Supplement 3Labeling	Approved	None posted
May 12, 1998	Supplement 5Labeling	Approved	None posted
May 12, 1998	Supplement 7Labeling	Approved	None posted
May 27, 1987	Supplement 13Labeling	Approved	None posted
May 13, 1985	Supplement 12Labeling	Approved	None posted
Feb 4, 1981	Supplement 9Labeling	Approved	None posted
Sep 17, 1980	Supplement 6Labeling	Approved	None posted
Sep 12, 1980	Supplement 8Labeling	Approved	None posted
Jun 2, 1975	Supplement 2Labeling	Approved	None posted
Feb 19, 1948	Original application	Approved	None posted

Identifiers

Application: NDA 6328
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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