Tornalate

NDA 18770, held by Sanofi Aventis US. Bitolterol Mesylate.

As of Nov 13, 2026, NDA 18770 (Tornalate), held by Sanofi Aventis US, was first approved by FDA on Dec 28, 1984, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1984
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Dec 7, 2007	Supplement 11Efficacy (new indication or use)	Approved	None posted
Dec 7, 2007	Supplement 4Efficacy (new indication or use)	Approved	None posted
Dec 28, 1984	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tornalate0.37MG/INH · aerosol, metered;inhalation	Bitolterol Mesylate	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 16Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 15Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 14Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 11Efficacy (new indication or use)	Approved	None posted
Dec 7, 2007	Supplement 8Labeling	Approved	None posted
Dec 7, 2007	Supplement 4Efficacy (new indication or use)	Approved	None posted
Jan 20, 1999	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 11, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 9, 1991	Supplement 13Labeling	Approved	None posted
Sep 24, 1986	Supplement 10Labeling	Approved	None posted
Aug 6, 1986	Supplement 7Labeling	Approved	None posted
Jan 17, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Jan 9, 1986	Supplement 5Labeling	Approved	None posted
Aug 14, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 11, 1985	Supplement 1Labeling	Approved	None posted
Dec 28, 1984	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18770
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