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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Queensland Health
US Department of Justice
Johnson and Johnson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077152

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NDA 077152 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 077152
Ingredient:terbutaline sulfate
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077152
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 077152 ANDA Lannett Company, Inc. 0527-1311 0527-1311-01 100 TABLET in 1 BOTTLE (0527-1311-01)
TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 077152 ANDA Lannett Company, Inc. 0527-1311 0527-1311-10 1000 TABLET in 1 BOTTLE (0527-1311-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 25, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 25, 2005TE:RLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Argus Health
Boehringer Ingelheim
Express Scripts

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