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Chubb
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Colorcon
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US Army
Harvard Business School
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Deloitte
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076887

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NDA 076887 describes TERBUTALINE SULFATE, which is a drug marketed by Akorn, Athenex Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Teva Pharms Usa, United Biomedcl, Impax Labs, and Lannett Co Inc, and is included in eight NDAs. It is available from fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 076887
Tradename:TERBUTALINE SULFATE
Applicant:Fresenius Kabi Usa
Ingredient:terbutaline sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076887
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 076887 ANDA General Injectables & Vaccines, Inc 52584-665 N 52584-665-01
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 076887 ANDA APP Pharmaceuticals, LLC 63323-665 N 63323-665-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:May 26, 2004TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Johnson and Johnson
US Army
Farmers Insurance
McKinsey
Federal Trade Commission
Chinese Patent Office
Merck
Mallinckrodt

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