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FDA ANDA · ANDA213471

MONTELUKAST SODIUM

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA213471
TYPE
ANDA
ORIGINAL APPROVAL
2020-02-18
LATEST ACTION
2021-07-30
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

MONTELUKAST SODIUMPrescription
MONTELUKAST SODIUM EQ 4MG BASE/PACKET · GRANULE · ORAL

Approval history

2021-07-30Labeling · Supplement 2 · standardAP
2021-07-30Labeling · Supplement 1 · standardAP
2020-02-18UNKNOWN · 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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