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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065311

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NDA 065311 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 065311
Tradename:CEFADROXIL
Applicant:Hikma
Ingredient:cefadroxil/cefadroxil hemihydrate
Patents:0
Pharmacology for NDA: 065311
Ingredient-typeCephalosporins
Suppliers and Packaging for NDA: 065311
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 065311 ANDA West-Ward Pharmaceuticals Corp 0143-9947 0143-9947-01 100 CAPSULE in 1 BOTTLE (0143-9947-01)
CEFADROXIL cefadroxil/cefadroxil hemihydrate CAPSULE;ORAL 065311 ANDA West-Ward Pharmaceuticals Corp 0143-9947 0143-9947-20 20 CAPSULE in 1 BOTTLE (0143-9947-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 500MG BASE
Approval Date:Feb 7, 2006TE:ABRLD:No

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