BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cerilliant
McKesson
Chinese Patent Office
Johnson and Johnson
Covington
US Army
Federal Trade Commission
Express Scripts
Medtronic
Cipla

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078630

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NDA 078630 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 078630
Tradename:TERBUTALINE SULFATE
Applicant:Hikma Farmaceutica
Ingredient:terbutaline sulfate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBUTALINE SULFATE terbutaline sulfate INJECTABLE;INJECTION 078630 ANDA West-ward Pharmaceutical Corp 0143-9746 0143-9746-10 10 VIAL in 1 CARTON (0143-9746-10) > 1 mL in 1 VIAL (0143-9746-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:May 20, 2009TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
Cipla
Healthtrust
QuintilesIMS
Boehringer Ingelheim
Cantor Fitzgerald
Colorcon
Harvard Business School
Express Scripts

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