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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202906
Company: DR REDDYS LABS LTD

Products on ANDA 202906

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 202906

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2020	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/07/2019	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/07/2019	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/07/2019	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/07/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/07/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/14/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/31/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/30/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202906

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
SINGULAIR	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Prescription	Yes	AB	021409	ORGANON

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