APPLICATION
ANDA203037
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-30
LATEST ACTION
2015-12-08
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 5MG BASE · TABLET, CHEWABLE · ORAL
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 4MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2015-12-08Labeling · Supplement 5 · standardAP
2015-03-20Labeling · Supplement 3 · standardAP
2015-03-20Labeling · Supplement 1 · standardAP
2015-03-20Labeling · Supplement 4 · standardAP
2014-10-30UNKNOWN · 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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