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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078723
Company: TEVA PHARMS

Products on ANDA 078723

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 078723

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/2012/078723Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/2020	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/01/2020	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/18/2018	SUPPL-11	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/12/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
03/16/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/16/2015	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/25/2013	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/06/2013	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
12/13/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/12/2012	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078723

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	205107	AMNEAL PHARMS
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	201581	DR REDDYS LABS LTD
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	209011	RISING
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	091414	SANDOZ INC
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	203037	UNIMARK REMEDIES LTD
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	205107	AMNEAL PHARMS
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	201581	DR REDDYS LABS LTD
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	209011	RISING
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	091414	SANDOZ INC
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	203037	UNIMARK REMEDIES LTD
SINGULAIR	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	020830	ORGANON

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