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Details for New Drug Application (NDA): 065260

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NDA 065260 describes CEFADROXIL, which is a drug marketed by Orchid Hlthcare, Hikma, Ranbaxy Labs Ltd, Sun Pharm Inds Ltd, Purepac Pharm, Ranbaxy, Apothecon, Hikma Pharms, Aurobindo, Aurobindo Pharma, Ivax Sub Teva Pharms, Teva Pharms, Ani Pharms Inc, Sandoz, Lupin, and Teva, and is included in twenty-two NDAs. It is available from twenty-five suppliers. Additional details are available on the CEFADROXIL profile page.

The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Twenty-five suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.

Summary for NDA: 065260

cefadroxil/cefadroxil hemihydrate

Pharmacology for NDA: 065260


Suppliers and Packaging for NDA: 065260

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cefadroxil/cefadroxil hemihydrate
TABLET;ORAL 065260 ANDA West-Ward Pharmaceutical Corp 0143-9948 0143-9948-01 100 TABLET, FILM COATED in 1 BOTTLE (0143-9948-01)
cefadroxil/cefadroxil hemihydrate
TABLET;ORAL 065260 ANDA West-Ward Pharmaceutical Corp 0143-9948 0143-9948-50 50 TABLET, FILM COATED in 1 BOTTLE (0143-9948-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1GM BASE
Approval Date:Mar 30, 2006TE:ABRLD:No

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