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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050821


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NDA 050821 describes CEFEPIME 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 CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER profile page.

The generic ingredient in CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER is cefepime hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.
Summary for 050821
Tradename:CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
Applicant:B Braun
Ingredient:cefepime hydrochloride
Patents:0
Pharmacology for NDA: 050821
Suppliers and Packaging for NDA: 050821
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER cefepime hydrochloride INJECTABLE;INJECTION 050821 NDA B. Braun Medical Inc. 0264-3193 0264-3193-11 24 CONTAINER in 1 CASE (0264-3193-11) / 50 mL in 1 CONTAINER
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER cefepime hydrochloride INJECTABLE;INJECTION 050821 NDA B. Braun Medical Inc. 0264-3195 0264-3195-11 24 CONTAINER in 1 CASE (0264-3195-11) / 50 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:May 6, 2010TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:May 6, 2010TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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