Terbutaline Sulfate

ANDA 78151, held by Epic Pharma LLC. Terbutaline Sulfate.

As of Nov 15, 2026, ANDA 78151 (Terbutaline Sulfate), held by Epic Pharma LLC, was first approved by FDA on Jan 7, 2008, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 7, 2008
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 7, 2008	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Apr 8, 2011	Supplement 1Labeling	Approved	None posted
Jan 7, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78151
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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