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Serving leading biopharmaceutical companies globally:

UBS
Moodys
Medtronic
Queensland Health
Argus Health
Chinese Patent Office
AstraZeneca
McKinsey
Novartis
Teva

Generated: October 20, 2017

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 United Biomedcl, Hikma Farmaceutica, Akorn, Lannett, Teva Pharms Usa, Athenex Inc, Impax Labs, and Fresenius Kabi Usa, 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 NDA: 200122

Tradename:
1
Applicant:
1
Ingredient:
1
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 10271-101-10 10 VIAL in 1 BOX (10271-101-10) > 1 mL in 1 VIAL
TERBUTALINE SULFATE
terbutaline sulfate
INJECTABLE;INJECTION 200122 ANDA Athenex Pharmaceutical Division, LLC. 70860-801 70860-801-01 10 VIAL in 1 CARTON (70860-801-01) > 1 mL in 1 VIAL

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

AstraZeneca
Covington
Johnson and Johnson
QuintilesIMS
Teva
Fuji
Accenture
Dow
Deloitte
Boehringer Ingelheim

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