➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090372

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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. Six suppliers are listed for this compound. Additional details are available on the zafirlukast profile page.
Summary for 090372
Applicant:Dr Reddys Labs Ltd
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 50268-805-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-805-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-805-11)
ZAFIRLUKAST zafirlukast TABLET;ORAL 090372 ANDA Dr. Reddys Laboratories Limited 55111-625 55111-625-01 100 TABLET, FILM COATED in 1 BOTTLE (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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.