APPLICATION
ANDA202859
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-30
LATEST ACTION
2015-12-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2015-12-08Labeling · Supplement 5 · standardAP
2015-06-25Manufacturing (CMC) · Supplement 2 · unknownAP
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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