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Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075877

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NDA 075877 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 075877
Applicant:Impax Labs
Ingredient:terbutaline sulfate
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075877
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 075877 ANDA Impax Generics 0115-2611 N 0115-2611-03
TERBUTALINE SULFATE terbutaline sulfate TABLET;ORAL 075877 ANDA Impax Generics 0115-2611 N 0115-2611-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jun 26, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 26, 2001TE:ABRLD:No

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