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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210431
Company: TORRENT

Products on ANDA 210431

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2025	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/15/2021	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/24/2020	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/24/2020	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/24/2020	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210431

MONTELUKAST SODIUM

GRANULE;ORAL; EQ 4MG BASE/PACKET
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Prescription	No	AB	203438	AJANTA PHARMA LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Prescription	No	AB	213471	AUROBINDO PHARMA LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Prescription	No	AB	202906	DR REDDYS LABS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Prescription	No	AB	210431	TORRENT

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