NDAORALTABLET, CHEWABLE
Approved
Feb 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Clinical Trials (5)
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fasted Healthy Volunteers
Started Dec 2018
30 enrolled
Healthy Volunteers
Bioequivalence Study of Montelukast Sodium Oral Thin Film and Chewable Tablet in Fed Healthy Volunteers
Started Nov 2018
30 enrolled
Healthy Volunteers
Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects
Started Feb 2015
18 enrolled
Respiratory Disorders
A Bioequivalence Study of Montelukast From Asmakast 10mg Tabs (Sandoz, Egypt) & Singulair 10mg Tabs (Merck)
Started Aug 2014
26 enrolled
Healthy
Bioequivalence Study of Montelukast From Asmakast 5mg Chewable Tab.(Sandoz, Egypt) & Singulair 5mg Chewable Tab.(Merck)
Started Apr 2014
24 enrolled
Healthy