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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. Ten suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.

Summary for NDA: 050821

Tradename:
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
Applicant:
B Braun
Ingredient:
cefepime hydrochloride
Patents:0
Therapeutic Class:Antibacterials

Pharmacology for NDA: 050821

Ingredient-typeCephalosporins

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:May 6, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:May 6, 2010TE:RLD:No


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