Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fuji
Queensland Health
Merck
Harvard Business School
Julphar
Daiichi Sankyo
Teva
Colorcon

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091649

« Back to Dashboard

NDA 091649 describes CAPECITABINE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Eugia Pharma, Mylan Pharms Inc, Shilpa Medicare Ltd, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 091649
Tradename:CAPECITABINE
Applicant:Teva Pharms Usa
Ingredient:capecitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091649
Medical Subject Heading (MeSH) Categories for 091649
Suppliers and Packaging for NDA: 091649
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPECITABINE capecitabine TABLET;ORAL 091649 ANDA Teva Pharmaceuticals USA, Inc. 0093-7473 N 0093-7473-06
CAPECITABINE capecitabine TABLET;ORAL 091649 ANDA Teva Pharmaceuticals USA, Inc. 0093-7474 N 0093-7474-89

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Sep 16, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Sep 16, 2013TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Queensland Health
Julphar
Chubb
Healthtrust
AstraZeneca
McKesson
QuintilesIMS
Farmers Insurance

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.