Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:


Last Updated: January 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207456

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 207456 describes CAPECITABINE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Hikma, Msn Labs Pvt Ltd, Mylan, Shilpa Medicare Ltd, Sun Pharm, and Teva Pharms Usa, and is included in ten NDAs. It is available from twenty suppliers. Additional details are available on the CAPECITABINE profile page.

The generic ingredient in CAPECITABINE is capecitabine. There are twenty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 207456
Applicant:Shilpa Medicare Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 207456
Medical Subject Heading (MeSH) Categories for 207456
Suppliers and Packaging for NDA: 207456
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 207456 ANDA Rising Pharmaceuticals, Inc. 64980-276 64980-276-06 60 TABLET, FILM COATED in 1 BOTTLE (64980-276-06)
CAPECITABINE capecitabine TABLET;ORAL 207456 ANDA Rising Pharmaceuticals, Inc. 64980-277 64980-277-12 120 TABLET, FILM COATED in 1 BOTTLE (64980-277-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 12, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 12, 2016TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School

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 verifification 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.