APPLICATION
ANDA202717
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-21
LATEST ACTION
2023-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL
Approval history
2023-11-21Labeling · Supplement 20 · standardAP
2021-01-25Labeling · Supplement 16 · standardAP
2019-11-07Labeling · Supplement 14 · standardAP
2019-11-07Labeling · Supplement 15 · standardAP
2018-05-18Labeling · Supplement 10 · standardAP
2015-03-16Labeling · Supplement 9 · standardAP
2015-03-16Labeling · Supplement 7 · standardAP
2015-03-16Labeling · Supplement 5 · standardAP
2013-08-23Labeling · Supplement 3 · standardAP
2013-04-29Labeling · Supplement 2 · standardAP
2012-12-17Labeling · Supplement 1 · standardAP
2012-09-21UNKNOWN · 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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