APPLICATION
ANDA203582
TYPE
ANDA
ORIGINAL APPROVAL
2015-03-12
LATEST ACTION
2023-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 5MG BASE · TABLET, CHEWABLE · ORAL
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 4MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2023-07-31Labeling · Supplement 13 · standardAP
2023-07-31Labeling · Supplement 16 · standardAP
2023-07-31Labeling · Supplement 22 · standardAP
2023-07-31Labeling · Supplement 20 · standardAP
2023-07-31Labeling · Supplement 10 · standardAP
2023-07-31Labeling · Supplement 4 · standardAP
2015-09-25Manufacturing (CMC) · Supplement 1 · unknownAP
2015-03-12UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.