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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Teva
McKinsey
Accenture
Colorcon
UBS
Queensland Health
Citi
McKesson

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065259

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NDA 065259 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-one 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-one suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Summary for 065259
Tradename:CEFDINIR
Applicant:Lupin
Ingredient:cefdinir
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065259
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065259 ANDA Aidarex Pharmaceuticals LLC 33261-905 N 33261-905-00
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065259 ANDA Rebel Distributors Corp 42254-127 E 42254-127-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:May 31, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:May 7, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
US Army
Daiichi Sankyo
Accenture
Farmers Insurance
QuintilesIMS
Boehringer Ingelheim
Argus Health
Medtronic

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