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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205683
Company: ANBISON LAB

Products on ANDA 205683

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205683

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/2016	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
10/02/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/02/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205683

MONTELUKAST SODIUM

TABLET;ORAL; EQ 10MG 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 10MG BASE	TABLET;ORAL	Prescription	No	AB	202717	ACCORD HLTHCARE
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	204604	AMNEAL PHARMS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	205683	ANBISON LAB
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202468	AUROBINDO PHARMA LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	201522	CHARTWELL MOLECULAR
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	207463	CIPLA
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	201582	DR REDDYS LABS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	090926	GLENMARK PHARMS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202843	HETERO LABS LTD V
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	203366	MACLEODS PHARMS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	202859	PHARMOBEDIENT
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	209012	RISING
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	200889	SANDOZ INC
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	078605	TEVA PHARMS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	201515	TORRENT PHARMS LTD
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	No	AB	204290	UNICHEM
SINGULAIR	MONTELUKAST SODIUM	EQ 10MG BASE	TABLET;ORAL	Prescription	Yes	AB	020829	ORGANON

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