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Generated: November 19, 2018

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Details for New Drug Application (NDA): 065214

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NDA 065214 describes CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER profile page.

The generic ingredient in CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER is cefoxitin sodium. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefoxitin sodium profile page.
Summary for 065214
Tradename:CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
Applicant:B Braun
Ingredient:cefoxitin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065214
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065214
Suppliers and Packaging for NDA: 065214
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER cefoxitin sodium INJECTABLE;INJECTION 065214 NDA B. Braun Medical Inc. 0264-3123 0264-3123-11 24 CONTAINER in 1 CASE (0264-3123-11) > 50 mL in 1 CONTAINER
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER cefoxitin sodium INJECTABLE;INJECTION 065214 NDA B. Braun Medical Inc. 0264-3125 0264-3125-11 24 CONTAINER in 1 CASE (0264-3125-11) > 50 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Mar 10, 2006TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Mar 10, 2006TE:APRLD:Yes

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