APPLICATION
ANDA079103
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2020-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2020-08-18Labeling · Supplement 16 · standardAP
2019-10-22Labeling · Supplement 14 · standardAP
2019-10-22Labeling · Supplement 15 · standardAP
2015-10-08Labeling · Supplement 9 · standardAP
2015-03-16Labeling · Supplement 5 · standardAP
2015-03-16Labeling · Supplement 8 · standardAP
2015-03-16Labeling · Supplement 4 · 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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