APPLICATION
ANDA201581
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-06
LATEST ACTION
2023-11-27
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 4MG BASE · TABLET, CHEWABLE · ORAL
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 5MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2023-11-27Labeling · Supplement 10 · standardAP
2020-11-10Labeling · Supplement 9 · standardAP
2020-11-10Labeling · Supplement 7 · standardAP
2020-11-10Labeling · Supplement 8 · standardAP
2020-11-10Labeling · Supplement 6 · standardAP
2013-08-06Labeling · Supplement 4 · standardAP
2013-02-05Labeling · Supplement 2 · standardAP
2012-12-10Labeling · Supplement 1 · standardAP
2012-08-06Not Applicable · 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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