General MedicationsORALGeneric
SPECTRACEF
CEFDITOREN PIVOXIL
Standard Dose
400MG
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 SPECTRACEF is listed in Drugs@FDA under application 021222 (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 SPECTRACEF is listed in Drugs@FDA under application 021222 (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 CEFDITOREN PIVOXIL Form and strength TABLET;ORAL - 400MG Sponsor VANSEN PHARMA Submission history Latest submission status date: 2012-08-06 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.