← FDA Drug Approvals (Drugs@FDA)
SINGULAIR
NDA · New Drug Application · Sponsor: ORGANON · Approved 2002-07-26
Drug application
- FDA Application #
NDA021409- Application type
- New Drug Application
- Brand name
- SINGULAIR
- Generic name
- MONTELUKAST SODIUM
- Active ingredients
- MONTELUKAST SODIUM
- Dosage form
- GRANULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ORGANON
- Manufacturer
- Organon LLC
- First approval
- 2002-07-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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