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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Teva
Medtronic
Covington
Baxter
Colorcon
AstraZeneca
Cerilliant
Federal Trade Commission

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065473

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NDA 065473 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 065473
Tradename:CEFDINIR
Applicant:Aurobindo Pharma
Ingredient:cefdinir
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065473
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065473
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065473 ANDA NorthStar Rx LLC 16714-392 N 16714-392-02
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065473 ANDA NorthStar Rx LLC 16714-392 N 16714-392-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Dec 14, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Dec 14, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Accenture
McKinsey
Medtronic
Chinese Patent Office
McKesson
US Army
AstraZeneca
Teva

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