Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
US Army

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204835

« Back to Dashboard

NDA 204835 describes CEFIXIME, which is a drug marketed by Aurobindo Pharma Ltd and Belcher Pharms Llc and is included in three NDAs. It is available from three suppliers. Additional details are available on the CEFIXIME profile page.

The generic ingredient in CEFIXIME is cefixime. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefixime profile page.

Summary for 204835

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 204835


Medical Subject Heading (MeSH) Categories for 204835

Suppliers and Packaging for NDA: 204835

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFIXIME cefixime FOR SUSPENSION;ORAL 204835 ANDA Aurobindo Pharma Limited 65862-751 65862-751-50 50 mL in 1 BOTTLE (65862-751-50)
CEFIXIME cefixime FOR SUSPENSION;ORAL 204835 ANDA Aurobindo Pharma Limited 65862-751 65862-751-01 100 mL in 1 BOTTLE (65862-751-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength100MG/5ML
Approval Date:Apr 14, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Apr 14, 2015TE:ABRLD:No

Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch: