Drug Index
OMNICEF
Generic: CEFDINIR
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
- Route: ORAL
- Class: General Medications
- Safety profile: generic
- Latest regulatory update: 18 Nov 2015, 12:00 am (UTC)
Structured Monograph
Approval overview OMNICEF is listed in Drugs@FDA under application 050749 (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 CEFDINIR Form and strength FOR SUSPENSION;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE Submission history Latest submission status date: 2015-11-18 00:00:00. Submission type: SUPPL.