Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216109

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

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN SODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 2GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216109
Product Number: 001
Approval Date: Oct 7, 2022
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN SODIUM
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 3GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216109
Product Number: 002
Approval Date: Oct 7, 2022
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information