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Details for New Drug Application (NDA): 091036

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NDA 091036 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: 091036

Tradename:
CEFADROXIL
Applicant:
Hikma Pharms
Ingredient:
cefadroxil/cefadroxil hemihydrate
Patents:0

Pharmacology for NDA: 091036

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 091036

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFADROXIL
cefadroxil/cefadroxil hemihydrate
FOR SUSPENSION;ORAL 091036 ANDA West-Ward Pharmaceuticals Corp 0143-9766 0143-9766-01 100 mL in 1 BOTTLE (0143-9766-01)
CEFADROXIL
cefadroxil/cefadroxil hemihydrate
FOR SUSPENSION;ORAL 091036 ANDA West-Ward Pharmaceuticals Corp 0143-9766 0143-9766-75 75 mL in 1 BOTTLE (0143-9766-75)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Nov 28, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 500MG BASE/5ML
Approval Date:Nov 28, 2012TE:ABRLD:No


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