General MedicationsINTRAMUSCULAR, INTRAVENOUSGeneric

ZINACEF

CEFUROXIME SODIUM

Standard Dose

EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview ZINACEF is listed in Drugs@FDA under application 050558 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CEFUROXIME SODIUM Form and strength INJECTABLE;INTRAMUSCULAR, INTRAVENOUS - EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PAI HOLDINGS PHARM Submission history Latest submission status date: 2021-05-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZINACEF is listed in Drugs@FDA under application 050558 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CEFUROXIME SODIUM Form and strength INJECTABLE;INTRAMUSCULAR, INTRAVENOUS - EQ 750MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PAI HOLDINGS PHARM Submission history Latest submission status date: 2021-05-16 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.