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Daiichi Sankyo
US Army
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Federal Trade Commission
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Generated: April 24, 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 twenty-four 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. Twenty-four 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 Lupin Pharmaceuticals, Inc. 68180-722 N 68180-722-10

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:

Farmers Insurance
Mallinckrodt
Colorcon
Johnson and Johnson
Chinese Patent Office
US Department of Justice
Chubb
Covington
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