NDAORALTABLET
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Mechanism of Action
CLINICAL PHARMACOLOGY The pharmacokinetic data were derived from the capsule formulation; however, bioequivalence has been demonstrated for the oral solution, capsule, tablet, and suspension formulations under fasting conditions. Following oral administration of cefprozil to fasting subjects,…
Clinical Trials (5)
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Fed Conditions
Started Jun 2004
24 enrolled
Healthy
Cefprozil for Oral Suspension 250 mg/5 mL, Non-fasting
Started May 2004
26 enrolled
Healthy
To Demonstrate the Relative Bioavailability of Cefzil 250 mg/5 ml Cefprozil Oral Suspension Following a 10 ml Dose Fasting Conditions.
Started May 2004
20 enrolled
Healthy
Cefprozil for Oral Suspension 250 mg/5 mL, Fasting
Started Apr 2004
26 enrolled
Healthy
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions
Started Mar 2004
26 enrolled
Healthy