APPLICATION
ANDA204290
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-08
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2023-06-28Labeling · Supplement 26 · standardAP
2023-06-28Labeling · Supplement 12 · standardAP
2023-06-28Labeling · Supplement 17 · standardAP
2023-06-28Labeling · Supplement 13 · standardAP
2018-05-14Labeling · Supplement 7 · standardAP
2016-04-19Labeling · Supplement 1 · standardAP
2016-04-19Labeling · Supplement 2 · standardAP
2015-10-08UNKNOWN · 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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