APPLICATION
ANDA205695
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-05
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 4MG BASE · TABLET, CHEWABLE · ORAL
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 5MG BASE · TABLET, CHEWABLE · ORAL
Approval history
2023-06-28Labeling · Supplement 1 · standardAP
2023-06-28Labeling · Supplement 4 · standardAP
2015-11-05UNKNOWN · 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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