Proventil

NDA 17853, held by Schering. Albuterol Sulfate.

As of Nov 13, 2026, NDA 17853 (Proventil), held by Schering, was first approved by FDA on May 7, 1982, with 12 approved supplements and 0 published complete response letters.

First approved: May 7, 1982
Review: Standard
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
May 7, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


ProventilEQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Albuterol Sulfate	DiscontinuedReference drug
ProventilEQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Albuterol Sulfate	DiscontinuedReference drug

All 13 submissions, including labeling and manufacturing supplements


Aug 12, 1999	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 6, 1998	Supplement 16Labeling · Standard review	Approved	Review
Aug 10, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 9, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 15, 1992	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 24, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 8, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 16, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 24, 1985	Supplement 7Labeling · Standard review	Approved	None posted
Dec 24, 1985	Supplement 6Labeling · Standard review	Approved	None posted
May 24, 1985	Supplement 1Labeling · Standard review	Approved	None posted
Dec 4, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
May 7, 1982	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17853
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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