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Generated: April 26, 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, 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
Tradename:TERBUTALINE SULFATE
Applicant:United Biomedcl
Ingredient:terbutaline sulfate
Patents:0
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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