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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065337

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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-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 065337
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065337
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

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Cantor Fitzgerald

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