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Serving leading biopharmaceutical companies globally:

Cipla
US Department of Justice
Federal Trade Commission
Teva
Chubb
Novartis
Queensland Health
Covington
Farmers Insurance
Moodys

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065368

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NDA 065368 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 065368
Tradename:CEFDINIR
Applicant:Teva Pharms
Ingredient:cefdinir
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065368
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFDINIR cefdinir CAPSULE;ORAL 065368 ANDA Teva Pharmaceuticals USA Inc 0093-3160 N 0093-3160-06
CEFDINIR cefdinir CAPSULE;ORAL 065368 ANDA Rebel Distributors Corp 42254-177 E 42254-177-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:May 9, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Dow
Julphar
Teva
Harvard Business School
Deloitte
Citi
Fish and Richardson
Cerilliant

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