APPLICATION
ANDA201522
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2023-08-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2023-08-07Labeling · Supplement 18 · standardAP
2023-08-07Labeling · Supplement 17 · standardAP
2020-10-08Labeling · Supplement 14 · standardAP
2020-10-08Labeling · Supplement 12 · standardAP
2020-10-08Labeling · Supplement 10 · standardAP
2018-07-23Labeling · Supplement 9 · standardAP
2016-06-02Labeling · Supplement 6 · standardAP
2016-01-06Manufacturing (CMC) · Supplement 3 · unknownAP
2013-08-22Labeling · Supplement 4 · standardAP
2013-01-31Labeling · Supplement 2 · standardAP
2012-09-18Labeling · 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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