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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065349

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NDA 065349 describes CEFADROXIL, which is a drug marketed by Aurobindo Pharma, Cspc Ouyi Pharm Co, Hikma, Ivax Sub Teva Pharms, Lupin, Orchid Hlthcare, Purepac Pharm, Ranbaxy Labs Ltd, Sandoz, Teva, Teva Pharms, Ani Pharms Inc, Apothecon, Aurobindo, Hikma Pharms, Sun Pharm Inds Ltd, and Ranbaxy, and is included in twenty-three NDAs. It is available from twenty-eight suppliers. Additional details are available on the CEFADROXIL profile page.

The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Twenty-eight suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.
Summary for 065349
Tradename:CEFADROXIL
Applicant:Aurobindo
Ingredient:cefadroxil/cefadroxil hemihydrate
Patents:0
Pharmacology for NDA: 065349
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065349
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFADROXIL cefadroxil/cefadroxil hemihydrate FOR SUSPENSION;ORAL 065349 ANDA NorthStar Rx LLC 16714-389 16714-389-01 100 mL in 1 BOTTLE (16714-389-01)
CEFADROXIL cefadroxil/cefadroxil hemihydrate FOR SUSPENSION;ORAL 065349 ANDA NorthStar Rx LLC 16714-390 16714-390-01 75 mL in 1 BOTTLE (16714-390-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Apr 25, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 500MG BASE/5ML
Approval Date:Apr 25, 2013TE:ABRLD:No

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