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Serving leading biopharmaceutical companies globally:

US Army
US Department of Justice
Fish and Richardson
Chinese Patent Office
Queensland Health

Generated: December 17, 2017

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, and is included in eight NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

Summary for 076887

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 52584-665-01 1 VIAL in 1 BAG (52584-665-01) > 1 mL in 1 VIAL
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 076887 ANDA APP Pharmaceuticals, LLC 63323-665 63323-665-01 25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) > 1 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Federal Trade Commission
Queensland Health

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