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Serving 500+ biopharmaceutical companies globally:

Medtronic
Express Scripts
UBS
AstraZeneca
Chubb
Federal Trade Commission
Chinese Patent Office
Johnson and Johnson
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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065337

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NDA 065337 describes CEFDINIR, which is a drug marketed by Orchid Hlthcare, Sandoz, Teva Pharms, Aurobindo Pharma, and Lupin, and is included in ten NDAs. It is available from twenty-nine 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-nine suppliers are listed for this compound. Additional details are available on the cefdinir profile page.

Summary for NDA: 065337

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065337

Ingredient-typeCephalosporins

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 0781-6077-46 100 mL in 1 BOTTLE (0781-6077-46)
CEFDINIR
cefdinir
FOR SUSPENSION;ORAL 065337 ANDA Sandoz Inc 0781-6077 0781-6077-61 60 mL in 1 BOTTLE (0781-6077-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Apr 6, 2007TE:ABRLD:No

Summary 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 500+ biopharmaceutical companies globally:

Cipla
Colorcon
Harvard Business School
Deloitte
Queensland Health
US Army
Moodys
QuintilesIMS
Chinese Patent Office
AstraZeneca

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