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Generated: November 18, 2018

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Details for New Drug Application (NDA): 050779

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NDA 050779 describes CEFAZOLIN AND DEXTROSE, 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 CEFAZOLIN AND DEXTROSE profile page.

The generic ingredient in CEFAZOLIN AND DEXTROSE is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.
Summary for 050779
Tradename:CEFAZOLIN AND DEXTROSE
Applicant:B Braun
Ingredient:cefazolin sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050779
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 050779
Suppliers and Packaging for NDA: 050779
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFAZOLIN AND DEXTROSE cefazolin sodium INJECTABLE;INJECTION 050779 NDA B. Braun Medical Inc. 0264-3103 0264-3103-11 24 CONTAINER in 1 CASE (0264-3103-11) > 50 mL in 1 CONTAINER
CEFAZOLIN AND DEXTROSE cefazolin sodium INJECTABLE;INJECTION 050779 NDA B. Braun Medical Inc. 0264-3105 0264-3105-11 24 CONTAINER in 1 CASE (0264-3105-11) > 50 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jul 27, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jul 27, 2000TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Jan 13, 2012TE:RLD:Yes

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