APPLICATION
ANDA202096
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2022-01-19
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
2022-01-19Labeling · Supplement 25 · standardAP
2020-08-14Labeling · Supplement 22 · standardAP
2019-11-05Labeling · Supplement 21 · standardAP
2019-11-05Labeling · Supplement 18 · standardAP
2018-07-23Labeling · Supplement 16 · standardAP
2015-12-08Labeling · Supplement 13 · standardAP
2015-12-08Labeling · Supplement 10 · standardAP
2013-05-10Labeling · Supplement 6 · standardAP
2012-11-30Labeling · Supplement 4 · standardAP
2012-11-30Labeling · Supplement 2 · 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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