APPLICATION
ANDA203795
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-27
LATEST ACTION
2020-11-13
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
2020-11-13Labeling · Supplement 11 · standardAP
2020-11-13Labeling · Supplement 7 · standardAP
2020-11-13Labeling · Supplement 3 · standardAP
2020-11-13Labeling · Supplement 10 · standardAP
2015-12-07Labeling · Supplement 1 · standardAP
2015-02-27UNKNOWN · 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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