APPLICATION
ANDA201515
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2025-04-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2025-04-03Labeling · Supplement 19 · standardAP
2021-10-15Labeling · Supplement 17 · standardAP
2020-10-05Labeling · Supplement 13 · standardAP
2020-10-05Labeling · Supplement 16 · standardAP
2016-03-01Labeling · Supplement 3 · standardAP
2016-01-04Labeling · Supplement 8 · standardAP
2014-04-07Labeling · Supplement 7 · standardAP
2013-01-28Labeling · Supplement 2 · standardAP
2012-10-16Labeling · 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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