Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065306

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CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
EQ 10GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A065306
Product Number: 001
Approval Date: Oct 22, 2008
Applicant Holder Full Name: ACS DOBFAR SPA
Marketing Status:  Prescription
Patent and Exclusivity Information

CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
EQ 20GM BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CEFAZOLIN SODIUM
Proprietary Name: CEFAZOLIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A065306
Product Number: 002
Approval Date: Aug 18, 2014
Applicant Holder Full Name: ACS DOBFAR SPA
Marketing Status:  Prescription
Patent and Exclusivity Information