Terbutaline Sulfate

For asthma and reversible bronchospasm associated with bronchitis and emphysema. ANDA 76887, held by Fresenius Kabi USA. Terbutaline Sulfate.

As of Nov 15, 2026, ANDA 76887 (Terbutaline Sulfate), held by Fresenius Kabi USA, was first approved by FDA on May 26, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: May 26, 2004
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Terbutaline Sulfate Injection, USP is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 26, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Terbutaline Sulfate1MG/ML · injectable;injection	Terbutaline Sulfate	Rx

All 3 submissions, including labeling and manufacturing supplements


Oct 21, 2014	Supplement 7Manufacturing	Approved	None posted
Apr 8, 2011	Supplement 5Labeling	Approved	None posted
May 26, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76887
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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