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SINGULAIR

NDA · New Drug Application · Sponsor: ORGANON · Approved 1998-02-20

Drug application

FDA Application #
NDA020829
Application type
New Drug Application
Brand name
SINGULAIR
Generic name
MONTELUKAST SODIUM
Active ingredients
MONTELUKAST SODIUM
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
ORGANON
Manufacturer
Organon LLC
First approval
1998-02-20

Source

Authoritative
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