Alupent

NDA 17659, held by Boehringer Ingelheim. Metaproterenol Sulfate.

As of Nov 14, 2026, NDA 17659 (Alupent), held by Boehringer Ingelheim, was first approved by FDA on Sep 18, 1980, with 29 approved supplements and 0 published complete response letters.

First approved: Sep 18, 1980
Review: Priority
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Nov 14, 1991	Supplement 25Efficacy (new indication or use) · Priority review	Approved	None posted
Sep 18, 1980	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alupent5% · solution;inhalation	Metaproterenol Sulfate	Discontinued

All 30 submissions, including labeling and manufacturing supplements


May 1, 1997	Supplement 34Manufacturing · Priority review	Approved	None posted
Feb 13, 1997	Supplement 32Manufacturing · Priority review	Approved	None posted
Nov 1, 1996	Supplement 31Manufacturing · Priority review	Approved	None posted
Jul 2, 1992	Supplement 30Manufacturing · Priority review	Approved	None posted
Jul 2, 1992	Supplement 29Labeling · Priority review	Approved	None posted
Nov 14, 1991	Supplement 26Labeling · Priority review	Approved	None posted
Nov 14, 1991	Supplement 25Efficacy (new indication or use) · Priority review	Approved	None posted
Apr 12, 1988	Supplement 23Manufacturing · Priority review	Approved	None posted
Oct 29, 1986	Supplement 24Labeling · Priority review	Approved	None posted
Feb 14, 1986	Supplement 22Labeling · Priority review	Approved	None posted
Jan 31, 1986	Supplement 21Labeling · Priority review	Approved	None posted
Jan 31, 1986	Supplement 20Manufacturing · Priority review	Approved	None posted
Jan 31, 1986	Supplement 19Labeling · Priority review	Approved	None posted
Jan 31, 1986	Supplement 18Manufacturing · Priority review	Approved	None posted
Jun 19, 1985	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 30, 1983	Supplement 15Labeling · Priority review	Approved	None posted
Mar 3, 1983	Supplement 14Manufacturing · Priority review	Approved	None posted
Jan 5, 1983	Supplement 11Manufacturing · Priority review	Approved	None posted
Nov 5, 1982	Supplement 12Manufacturing · Priority review	Approved	None posted
Apr 30, 1982	Supplement 10Labeling · Priority review	Approved	None posted
Mar 22, 1982	Supplement 9Labeling · Priority review	Approved	None posted
Mar 22, 1982	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 12, 1982	Supplement 7Manufacturing · Priority review	Approved	None posted
Sep 11, 1981	Supplement 6Manufacturing · Priority review	Approved	None posted
Jul 10, 1981	Supplement 4Manufacturing · Priority review	Approved	None posted
May 12, 1981	Supplement 5Labeling · Priority review	Approved	None posted
Mar 3, 1981	Supplement 3Manufacturing · Priority review	Approved	None posted
Feb 18, 1981	Supplement 2Labeling · Priority review	Approved	None posted
Jan 16, 1981	Supplement 1Labeling · Priority review	Approved	None posted
Sep 18, 1980	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 17659
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

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