Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050558

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ZINACEF (CEFUROXIME SODIUM)
EQ 1.5GM BASE/VIAL
Marketing Status: Discontinued

Active Ingredient: CEFUROXIME SODIUM
Proprietary Name: ZINACEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1.5GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050558
Product Number: 003
Approval Date: Oct 19, 1983
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZINACEF (CEFUROXIME SODIUM)
EQ 7.5GM BASE/VIAL
Marketing Status: Discontinued

Active Ingredient: CEFUROXIME SODIUM
Proprietary Name: ZINACEF
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 7.5GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050558
Product Number: 004
Approval Date: Oct 23, 1986
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ZINACEF (CEFUROXIME SODIUM)
EQ 750MG BASE/VIAL
Marketing Status: Discontinued

Active Ingredient: CEFUROXIME SODIUM
Proprietary Name: ZINACEF
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR, INTRAVENOUS
Strength: EQ 750MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050558
Product Number: 002
Approval Date: Oct 19, 1983
Applicant Holder Full Name: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information