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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Harvard Business School

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090372

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NDA 090372 describes ZAFIRLUKAST, which is a drug marketed by Dr Reddys Labs Ltd and is included in one NDA. It is available from four suppliers. Additional details are available on the ZAFIRLUKAST profile page.

The generic ingredient in ZAFIRLUKAST is zafirlukast. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.
Summary for 090372
Applicant:Dr Reddys Labs Ltd
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090372
Suppliers and Packaging for NDA: 090372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZAFIRLUKAST zafirlukast TABLET;ORAL 090372 ANDA AvPAK 50268-805 N 50268-805-12
ZAFIRLUKAST zafirlukast TABLET;ORAL 090372 ANDA Dr. Reddys Laboratories Limited 55111-625 N 55111-625-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 18, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 18, 2010TE:ABRLD:No

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