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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090984
Company: TORRENT PHARMS LTD

Products on ANDA 090984

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090984

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090984Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2025	SUPPL-17	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/15/2021	SUPPL-16	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/05/2020	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/05/2020	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/04/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/07/2014	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/14/2013	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/28/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/16/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090984

MONTELUKAST SODIUM

TABLET, CHEWABLE;ORAL; EQ 4MG BASE
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	TABLET, CHEWABLE;ORAL	Prescription	No	AB	205695	ANBISON LAB
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	202096	AUROBINDO PHARMA LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	207464	CHARTWELL MOLECULAR
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	204093	HETERO LABS LTD V
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	200405	LANNETT CO INC
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203582	MACLEODS PHARMS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203037	PHARMOBEDIENT
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	209011	RISING
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	201581	SENORES PHARMS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	078723	TEVA PHARMS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090984	TORRENT PHARMS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	208621	UNICHEM
SINGULAIR	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	020830	ORGANON

TABLET, CHEWABLE;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	205695	ANBISON LAB
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	202096	AUROBINDO PHARMA LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	207464	CHARTWELL MOLECULAR
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	204093	HETERO LABS LTD V
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	200405	LANNETT CO INC
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203582	MACLEODS PHARMS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	203037	PHARMOBEDIENT
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	209011	RISING
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	201581	SENORES PHARMS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	078723	TEVA PHARMS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090984	TORRENT PHARMS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	208621	UNICHEM
SINGULAIR	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	020830	ORGANON

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