General MedicationsINJECTIONGeneric
CEFOTAN
CEFOTETAN DISODIUM
Standard Dose
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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
Key Takeaways
- Primary indication: 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
- Approval overview CEFOTAN is listed in Drugs@FDA under application 050588 (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 CEFOTAN is listed in Drugs@FDA under application 050588 (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 CEFOTETAN DISODIUM Form and strength INJECTABLE;INJECTION - EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PAI HOLDINGS PHARM Submission history Latest submission status date: 2017-03-09 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.