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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 200122

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NDA 200122 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 nine 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. Ten suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

Summary for 200122

Tradename:	TERBUTALINE SULFATE
Applicant:	Areva Pharms
Ingredient:	terbutaline sulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 200122

Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Sympathomimetics
Tocolytic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Nov 8, 2013	TE:	AP	RLD:	No

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