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Details for New Drug Application (NDA): 065323

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NDA 065323 describes CEFUROXIME AXETIL, which is a drug marketed by Aurobindo Pharma Ltd, Sun Pharm Inds Ltd, Sandoz, Lupin, Ranbaxy Labs Ltd, Orchid Hlthcare, Wockhardt, Apotex, Ani Pharms Inc, and Alkem Labs Ltd, and is included in eleven NDAs. It is available from twenty-six suppliers. Additional details are available on the CEFUROXIME AXETIL profile page.

The generic ingredient in CEFUROXIME AXETIL is cefuroxime axetil. There are sixty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the cefuroxime axetil profile page.

Summary for NDA: 065323

Tradename:
CEFUROXIME AXETIL
Applicant:
Sun Pharm Inds Ltd
Ingredient:
cefuroxime axetil
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065323

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065323

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME AXETIL
cefuroxime axetil
FOR SUSPENSION;ORAL 065323 ANDA Ranbaxy Pharmaceuticals Inc 63304-963 63304-963-03 50 mL in 1 BOTTLE (63304-963-03)
CEFUROXIME AXETIL
cefuroxime axetil
FOR SUSPENSION;ORAL 065323 ANDA Ranbaxy Pharmaceuticals Inc 63304-963 63304-963-04 100 mL in 1 BOTTLE (63304-963-04)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 125MG BASE/5ML
Approval Date:Feb 5, 2008TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 250MG BASE/5ML
Approval Date:Feb 5, 2008TE:RLD:No


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