General MedicationsINJECTIONGeneric

ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER

CEFTRIAXONE SODIUM

Standard Dose

EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER is listed in Drugs@FDA under application 050624 (NDA).

Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Structured Monograph

Clinical summary

Approval overview ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER is listed in Drugs@FDA under application 050624 (NDA). Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Review priority: STANDARD Marketing status: Discontinued Active ingredient CEFTRIAXONE SODIUM Form and strength INJECTABLE;INJECTION - EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HOFFMANN LA ROCHE Submission history Latest submission status date: 2004-09-14 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.