APPLICATION
ANDA205107
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-04
LATEST ACTION
2025-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 5MG BASE · TABLET, CHEWABLE · ORAL
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 4MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2025-04-16Labeling · Supplement 1 · standardAP
2020-09-04UNKNOWN · Original · 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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