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FDA ANDA · ANDA207463

MONTELUKAST SODIUM

Sponsor: CIPLA

APPLICATION
ANDA207463
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-28
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 10MG BASE · TABLET · ORAL

Approval history

2024-02-15Labeling · Supplement 5 · standardAP
2020-07-23Labeling · Supplement 4 · standardAP
2020-07-23Labeling · Supplement 2 · standardAP
2020-07-23Labeling · Supplement 3 · standardAP
2018-05-14Labeling · Supplement 1 · standardAP
2016-10-28UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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