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Details for New Drug Application (NDA): 050823

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NDA 050823 describes CEFTAZIDIME IN DEXTROSE 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 CEFTAZIDIME IN DEXTROSE CONTAINER profile page.

The generic ingredient in CEFTAZIDIME IN DEXTROSE CONTAINER is ceftazidime. There are seventeen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ceftazidime profile page.

Summary for NDA: 050823

B Braun
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050823


Suppliers and Packaging for NDA: 050823

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 050823 NDA B. Braun Medical Inc. 0264-3143 0264-3143-11 24 CONTAINER in 1 CASE (0264-3143-11) > 50 mL in 1 CONTAINER
INJECTABLE;INJECTION 050823 NDA B. Braun Medical Inc. 0264-3145 0264-3145-11 24 CONTAINER in 1 CASE (0264-3145-11) > 50 mL in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE
Approval Date:Jun 13, 2011TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE
Approval Date:Jun 13, 2011TE:RLD:Yes

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