Bricanyl

NDA 17618, held by Sanofi Aventis US. Terbutaline Sulfate.

As of Nov 13, 2026, NDA 17618 (Bricanyl), held by Sanofi Aventis US, was first approved by FDA on Apr 22, 1975, with 33 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1975
Review: Standard
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below


Dec 7, 2007	Supplement 20Efficacy (new indication or use)	Approved	None posted
Dec 7, 2007	Supplement 19Efficacy (new indication or use)	Approved	None posted
Oct 8, 1997	Supplement 36Efficacy (new indication or use)	Approved	None posted
Apr 22, 1975	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Bricanyl2.5MG · tablet;oral	Terbutaline Sulfate	Discontinued
Bricanyl5MG · tablet;oral	Terbutaline Sulfate	Discontinued

All 34 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 35Labeling · Standard review	Approved	None posted
Dec 7, 2007	Supplement 22Labeling	Approved	None posted
Dec 7, 2007	Supplement 20Efficacy (new indication or use)	Approved	None posted
Dec 7, 2007	Supplement 19Efficacy (new indication or use)	Approved	None posted
Dec 24, 1997	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 8, 1997	Supplement 36Efficacy (new indication or use)	Approved	None posted
May 3, 1991	Supplement 31Manufacturing · Standard review	Approved	None posted
May 30, 1989	Supplement 30Manufacturing · Standard review	Approved	None posted
Feb 3, 1988	Supplement 32Labeling	Approved	None posted
Jul 15, 1986	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 10, 1986	Supplement 28Labeling	Approved	None posted
Feb 22, 1986	Supplement 24Labeling	Approved	None posted
Feb 22, 1986	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 27, 1985	Supplement 25Labeling	Approved	None posted
Apr 30, 1984	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 13, 1978	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 22, 1977	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 30, 1976	Supplement 14Labeling	Approved	None posted
Jun 30, 1976	Supplement 13Labeling	Approved	None posted
Jun 24, 1976	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 24, 1976	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 24, 1976	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 13, 1976	Supplement 11Labeling	Approved	None posted
Dec 10, 1975	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 10, 1975	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 4, 1975	Supplement 9Labeling	Approved	None posted
Nov 4, 1975	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 4, 1975	Supplement 6Labeling	Approved	None posted
Nov 4, 1975	Supplement 5Labeling	Approved	None posted
Jul 21, 1975	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 21, 1975	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 18, 1975	Supplement 2Labeling	Approved	None posted
Jun 18, 1975	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 22, 1975	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17618
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