Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050779

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CEFAZOLIN AND DEXTROSE (CEFAZOLIN SODIUM)
EQ 1GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN AND DEXTROSE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050779
Product Number: 002
Approval Date: Jul 27, 2000
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFAZOLIN AND DEXTROSE (CEFAZOLIN SODIUM)
EQ 2GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN AND DEXTROSE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050779
Product Number: 003
Approval Date: Jan 13, 2012
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFAZOLIN AND DEXTROSE (CEFAZOLIN SODIUM)
EQ 3GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN AND DEXTROSE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 3GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050779
Product Number: 004
Approval Date: Aug 26, 2024
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFAZOLIN AND DEXTROSE (CEFAZOLIN SODIUM)
EQ 500MG BASE/VIAL
Marketing Status: Discontinued

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN AND DEXTROSE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050779
Product Number: 001
Approval Date: Jul 27, 2000
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information