APPLICATION
ANDA091414
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2022-01-19
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 4MG BASE · TABLET, CHEWABLE · ORAL
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 5MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2022-01-19Labeling · Supplement 17 · standardAP
2020-09-04Labeling · Supplement 16 · standardAP
2020-09-04Labeling · Supplement 14 · standardAP
2019-10-01Labeling · Supplement 11 · standardAP
2018-07-26Labeling · Supplement 10 · standardAP
2015-05-04Labeling · Supplement 8 · standardAP
2015-05-04Labeling · Supplement 9 · standardAP
2013-06-26Labeling · Supplement 6 · standardAP
2013-01-28Labeling · Supplement 4 · 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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