Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 207131

Expand all

CEFAZOLIN IN DEXTROSE (CEFAZOLIN SODIUM)
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN IN DEXTROSE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207131
Product Number: 002
Approval Date: Feb 1, 2021
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFAZOLIN IN DEXTROSE (CEFAZOLIN SODIUM)
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN IN DEXTROSE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207131
Product Number: 001
Approval Date: Aug 7, 2015
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFAZOLIN IN DEXTROSE (CEFAZOLIN SODIUM)
EQ 3GM BASE/150ML (EQ 20MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN IN DEXTROSE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 3GM BASE/150ML (EQ 20MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207131
Product Number: 003
Approval Date: May 31, 2024
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information