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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Cantor Fitzgerald

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200122

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NDA 200122 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 200122
Applicant:United Biomedcl
Ingredient:terbutaline sulfate
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 200122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 200122 ANDA United Biomedical Inc., Asia 10271-101 N 10271-101-10
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 200122 ANDA Athenex Pharmaceutical Division, LLC. 70860-801 N 70860-801-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Nov 8, 2013TE:APRLD:No

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US Department of Justice
Argus Health

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