APPLICATION
ANDA090955
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2023-10-04
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued
Products
MONTELUKAST SODIUMDiscontinued
MONTELUKAST SODIUM EQ 4MG BASE/PACKET · GRANULE · ORAL
Approval history
2023-10-04Labeling · Supplement 14 · standardAP
2023-10-04Labeling · Supplement 15 · standardAP
2019-11-08Labeling · Supplement 12 · standardAP
2019-11-08Labeling · Supplement 10 · standardAP
2019-11-08Labeling · Supplement 13 · standardAP
2015-04-28Labeling · Supplement 7 · standardAP
2015-04-28Labeling · Supplement 6 · standardAP
2013-06-26Labeling · Supplement 5 · standardAP
2013-02-06Labeling · Supplement 4 · standardAP
2012-12-17Labeling · Supplement 2 · 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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