Alupent

NDA 16402, held by Boehringer Ingelheim. Metaproterenol Sulfate.

As of Nov 13, 2026, NDA 16402 (Alupent), held by Boehringer Ingelheim, was first approved by FDA on Jul 31, 1973, with 28 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1973
Review: Priority
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Jul 31, 1973	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alupent0.65MG/INH · aerosol, metered;inhalation	Metaproterenol Sulfate	Discontinued

All 29 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 26, 1997	Supplement 37Manufacturing · Priority review	Approved	None posted
Jul 16, 1997	Supplement 35Labeling · Priority review	Approved	None posted
Jul 8, 1994	Supplement 34Labeling · Priority review	Approved	None posted
Dec 7, 1989	Supplement 33Manufacturing · Priority review	Approved	None posted
Mar 17, 1989	Supplement 30Manufacturing · Priority review	Approved	None posted
Mar 17, 1989	Supplement 29Labeling · Priority review	Approved	None posted
Mar 17, 1989	Supplement 28Manufacturing · Priority review	Approved	None posted
Oct 9, 1986	Supplement 26Manufacturing · Priority review	Approved	None posted
Jul 24, 1986	Supplement 27Labeling · Priority review	Approved	None posted
Jun 4, 1986	Supplement 25Labeling · Priority review	Approved	None posted
Nov 29, 1985	Supplement 23Labeling · Priority review	Approved	None posted
May 17, 1985	Supplement 22Manufacturing · Priority review	Approved	None posted
Aug 21, 1984	Supplement 21Labeling · Priority review	Approved	None posted
Aug 16, 1984	Supplement 20Labeling · Priority review	Approved	None posted
Aug 16, 1984	Supplement 19Manufacturing · Priority review	Approved	None posted
Apr 1, 1982	Supplement 18Manufacturing · Priority review	Approved	None posted
Apr 1, 1982	Supplement 17Manufacturing · Priority review	Approved	None posted
Jun 24, 1981	Supplement 16Manufacturing · Priority review	Approved	None posted
Jan 4, 1980	Supplement 15Manufacturing · Priority review	Approved	None posted
Aug 1, 1979	Supplement 14Manufacturing · Priority review	Approved	None posted
Oct 20, 1978	Supplement 12Labeling · Priority review	Approved	None posted
Oct 13, 1978	Supplement 13Manufacturing · Priority review	Approved	None posted
May 25, 1977	Supplement 11Labeling · Priority review	Approved	None posted
Dec 22, 1976	Supplement 10Manufacturing · Priority review	Approved	None posted
Dec 22, 1976	Supplement 9Manufacturing · Priority review	Approved	None posted
Oct 7, 1976	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 18, 1974	Supplement 6Labeling · Priority review	Approved	None posted
Dec 18, 1974	Supplement 2Manufacturing · Priority review	Approved	None posted
Jul 31, 1973	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 16402
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