APPLICATION
ANDA201508
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2015-03-16
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
2015-03-16Labeling · Supplement 7 · standardAP
2015-03-16Labeling · Supplement 5 · standardAP
2013-08-14Labeling · Supplement 4 · standardAP
2012-12-13Labeling · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.