APPLICATION
ANDA203432
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-31
LATEST ACTION
2025-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2025-07-01Labeling · Supplement 16 · standardAP
2020-10-20Labeling · Supplement 10 · standardAP
2019-11-08Labeling · Supplement 1 · standardAP
2019-11-08Labeling · Supplement 7 · standardAP
2019-11-08Labeling · Supplement 5 · standardAP
2015-07-31UNKNOWN · 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.
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