Brethine

NDA 18571, held by Pharmacare. Terbutaline Sulfate.

As of Nov 13, 2026, NDA 18571 (Brethine), held by Pharmacare, was first approved by FDA on Nov 30, 1981, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1981
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Nov 30, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Brethine1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Terbutaline Sulfate	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 8, 2011	Supplement 23Labeling	Approved	None posted
Dec 19, 2003	Supplement 19Labeling · Standard review	Approved	Letter
Jan 25, 2002	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 17, 2001	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 21, 2000	Supplement 15Labeling · Standard review	Approved	None posted
Dec 11, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Dec 9, 1998	Supplement 14Manufacturing · Standard review	Approved	None posted
Sep 17, 1998	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 12, 1998	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 19, 1997	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 9, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 7, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 13, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 5, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Feb 9, 1989	Supplement 2Labeling	Approved	None posted
Feb 9, 1989	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 17, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 30, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18571
Drugs@FDA: Overview at FDA
Company: Pharmacare Ltd

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