PROZAC

LOE Approaching

fluoxetine hydrochloride

NDAORALSOLUTIONPriority Review
Approved
Apr 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5

Clinical Trials (5)

NCT01247272Phase 1Completed

90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions

Started May 2001
26 enrolled
Healthy
NCT01247285Phase 1Completed

90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions

Started May 2001
26 enrolled
Healthy
NCT00947076Phase 1Completed

To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg

Started Feb 2001
30 enrolled
Depression
NCT00913718Phase 1Completed

To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions

Started Jun 1996
46 enrolled
Depression
NCT00913588Phase 1Completed

To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions

Started May 1996
24 enrolled
Depression