You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 200122

✉ Email this page to a colleague

« Back to Dashboard

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 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 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

Suppliers and Packaging for NDA: 200122

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TERBUTALINE SULFATE	terbutaline sulfate	INJECTABLE;INJECTION	200122	ANDA	Areva Pharmaceuticals	59923-615	59923-615-05	5 VIAL, SINGLE-USE in 1 CARTON (59923-615-05) / 1 mL in 1 VIAL, SINGLE-USE (59923-615-01)

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.