Alupent

NDA 15874, held by Boehringer Ingelheim. Metaproterenol Sulfate.

As of Nov 13, 2026, NDA 15874 (Alupent), held by Boehringer Ingelheim, was first approved by FDA on May 13, 1974, with 36 approved supplements and 0 published complete response letters.

First approved: May 13, 1974
Review: Priority
Supplements approved: 36
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 37 submissions below

Date	Submission	Status	Documents
May 13, 1974	Original applicationNew dosage form · Priority review	Approved	None posted

Products

2 strengths and forms


Alupent20MG · tablet;oral	Metaproterenol Sulfate	Discontinued
Alupent10MG · tablet;oral	Metaproterenol Sulfate	Discontinued

All 37 submissions, including labeling and manufacturing supplements


Nov 12, 2002	Supplement 37Labeling · Standard review	Approved	None posted
Nov 12, 2002	Supplement 24Labeling	Approved	None posted
Apr 28, 1992	Supplement 35Labeling	Approved	None posted
Mar 11, 1991	Supplement 36Labeling	Approved	None posted
Feb 14, 1986	Supplement 34Labeling	Approved	None posted
Dec 10, 1985	Supplement 32Manufacturing · Priority review	Approved	None posted
Dec 10, 1985	Supplement 30Manufacturing · Priority review	Approved	None posted
May 4, 1984	Supplement 33Labeling	Approved	None posted
Nov 10, 1983	Supplement 31Labeling	Approved	None posted
May 5, 1983	Supplement 28Labeling	Approved	None posted
May 5, 1983	Supplement 27Manufacturing · Priority review	Approved	None posted
Jan 5, 1983	Supplement 29Manufacturing · Priority review	Approved	None posted
Feb 12, 1982	Supplement 26Manufacturing · Priority review	Approved	None posted
Jun 24, 1981	Supplement 25Manufacturing · Priority review	Approved	None posted
Apr 7, 1981	Supplement 23Manufacturing · Priority review	Approved	None posted
Sep 11, 1980	Supplement 22Manufacturing · Priority review	Approved	None posted
May 5, 1980	Supplement 17Manufacturing · Priority review	Approved	None posted
Jan 9, 1980	Supplement 21Manufacturing · Priority review	Approved	None posted
Jun 26, 1979	Supplement 20Manufacturing · Priority review	Approved	None posted
Jun 28, 1978	Supplement 19Labeling	Approved	None posted
Aug 8, 1977	Supplement 18Labeling	Approved	None posted
Aug 8, 1977	Supplement 12Manufacturing · Priority review	Approved	None posted
Dec 8, 1976	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 12, 1976	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 12, 1976	Supplement 13Manufacturing · Priority review	Approved	None posted
Oct 29, 1976	Supplement 16Manufacturing · Priority review	Approved	None posted
Sep 23, 1976	Supplement 6Labeling	Approved	None posted
Jul 20, 1976	Supplement 11Manufacturing · Priority review	Approved	None posted
Jul 20, 1976	Supplement 10Manufacturing · Priority review	Approved	None posted
Jul 19, 1976	Supplement 8Manufacturing · Priority review	Approved	None posted
Apr 26, 1976	Supplement 9Manufacturing · Priority review	Approved	None posted
Mar 11, 1976	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 19, 1974	Supplement 5Manufacturing · Priority review	Approved	None posted
Dec 19, 1974	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 19, 1974	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 19, 1974	Supplement 1Manufacturing · Priority review	Approved	None posted
May 13, 1974	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 15874
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