APPLICATION
ANDA078723
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2024-05-20
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
2024-05-20Labeling · Supplement 16 · standardAP
2020-07-23Labeling · Supplement 13 · standardAP
2020-04-01Labeling · Supplement 12 · standardAP
2018-05-18Labeling · Supplement 11 · standardAP
2015-11-12Labeling · Supplement 8 · standardAP
2015-03-16Labeling · Supplement 7 · standardAP
2015-03-16Labeling · Supplement 6 · standardAP
2013-06-25Labeling · Supplement 5 · standardAP
2013-02-06Labeling · Supplement 3 · standardAP
2012-12-13Labeling · Supplement 2 · standardAP
2012-10-12Labeling · 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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