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Deloitte
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Dow
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065332

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NDA 065332 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-two 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-two suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Summary for 065332
Tradename:CEFDINIR
Applicant:Teva Pharms
Ingredient:cefdinir
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065332
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065332 ANDA Teva Pharmaceuticals USA Inc 0093-4136 N 0093-4136-64
CEFDINIR cefdinir FOR SUSPENSION;ORAL 065332 ANDA Teva Pharmaceuticals USA Inc 0093-4136 N 0093-4136-73

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:May 4, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:May 4, 2007TE:ABRLD:No

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US Army
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