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

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Covington
Express Scripts
Julphar
Mallinckrodt
Baxter
AstraZeneca
McKinsey
Johnson and Johnson

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065337

« Back to Dashboard

NDA 065337 describes CEFDINIR, which is a drug marketed by Aurobindo Pharma, Lupin, Orchid Hlthcare, Sandoz, and Teva Pharms, and is included in ten NDAs. It is available from thirty-two suppliers. Additional details are available on the CEFDINIR profile page.

The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Summary for 065337
Tradename:CEFDINIR
Applicant:Sandoz
Ingredient:cefdinir
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065337
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065337
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065337 ANDA Sandoz Inc 0781-6077 N 0781-6077-46
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065337 ANDA Sandoz Inc 0781-6077 N 0781-6077-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Apr 6, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Apr 6, 2007TE: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:

Fuji
Chinese Patent Office
Deloitte
Cipla
Covington
McKesson
Queensland Health
Medtronic
Accenture

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.