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FDA ANDA · ANDA202843

MONTELUKAST

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA202843
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-10
LATEST ACTION
2023-09-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-09-21Labeling · Supplement 14 · standardAP
2021-01-29Labeling · Supplement 4 · standardAP
2021-01-29Labeling · Supplement 7 · standardAP
2021-01-29Labeling · Supplement 5 · standardAP
2018-07-30Labeling · Supplement 2 · standardAP
2014-09-10UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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