APPLICATION
ANDA207464
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-06
LATEST ACTION
2024-02-15
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
2024-02-15Labeling · Supplement 4 · standardAP
2020-07-23Labeling · Supplement 2 · standardAP
2020-07-23Labeling · Supplement 3 · standardAP
2020-07-23Labeling · Supplement 1 · standardAP
2018-12-06UNKNOWN · 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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