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Generated: April 19, 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 fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.
Summary for 077152
Tradename:TERBUTALINE SULFATE
Applicant:Lannett
Ingredient:terbutaline sulfate
Patents:0
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 N 0527-1311-01
TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 077152 ANDA Lannett Company, Inc. 0527-1311 N 0527-1311-10

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Teva
AstraZeneca
Boehringer Ingelheim
US Army
Federal Trade Commission
McKinsey
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Johnson and Johnson

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