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Details for New Drug Application (NDA): 065251

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NDA 065251 describes CEFUROXIME SODIUM IN PLASTIC CONTAINER, which is a drug marketed by Samson Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the CEFUROXIME SODIUM IN PLASTIC CONTAINER profile page.

The generic ingredient in CEFUROXIME SODIUM IN PLASTIC CONTAINER is cefuroxime sodium. There are sixty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefuroxime sodium profile page.

Summary for NDA: 065251

Tradename:
CEFUROXIME SODIUM IN PLASTIC CONTAINER
Applicant:
Samson Medcl
Ingredient:
cefuroxime sodium
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065251

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 065251

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFUROXIME SODIUM IN PLASTIC CONTAINER
cefuroxime sodium
INJECTABLE;INJECTION 065251 ANDA Samson Medical Technologies, L.L.C. 66288-2075 66288-2075-1 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-2075-1)
CEFUROXIME SODIUM IN PLASTIC CONTAINER
cefuroxime sodium
INJECTABLE;INJECTION 065251 ANDA Samson Medical Technologies, L.L.C. 66288-2225 66288-2225-1 1 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-2225-1)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 75GM BASE/VIAL
Approval Date:Dec 30, 2009TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 225GM BASE/VIAL
Approval Date:Dec 30, 2009TE:RLD:No


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