APPLICATION
ANDA091576
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2025-06-13Labeling · Supplement 21 · standardAP
2025-06-13Labeling · Supplement 22 · standardAP
2020-10-02Labeling · Supplement 18 · standardAP
2020-10-02Labeling · Supplement 20 · standardAP
2018-07-27Labeling · Supplement 14 · standardAP
2015-06-22Labeling · Supplement 8 · standardAP
2015-06-22Labeling · Supplement 6 · standardAP
2013-07-22Labeling · Supplement 5 · standardAP
2012-12-13Labeling · Supplement 3 · standardAP
2012-09-12Labeling · Supplement 1 · standardAP
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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