APPLICATION
ANDA203366
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-11
LATEST ACTION
2024-09-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2024-09-27Labeling · Supplement 25 · standardAP
2024-09-27Labeling · Supplement 34 · standardAP
2023-06-07Labeling · Supplement 30 · standardAP
2020-11-24Labeling · Supplement 20 · standardAP
2019-11-08Labeling · Supplement 13 · standardAP
2019-11-08Labeling · Supplement 16 · standardAP
2018-05-18Labeling · Supplement 7 · standardAP
2016-06-23Labeling · Supplement 1 · standardAP
2014-09-11UNKNOWN · 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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