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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078151

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NDA 078151 describes TERBUTALINE SULFATE, which is a drug marketed by Areva Pharms, Chartwell Injectable, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Hikma Farmaceutica, Impax Labs, Lannett Co Inc, and Twi Pharms, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the TERBUTALINE SULFATE profile page.

The generic ingredient in TERBUTALINE SULFATE is terbutaline sulfate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

Summary for 078151

Tradename:	TERBUTALINE SULFATE
Applicant:	Epic Pharma Llc
Ingredient:	terbutaline sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 078151

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Sympathomimetics
Tocolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Jan 7, 2008	TE:		RLD:	No

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