An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
10/15/2021	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/24/2020	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/24/2020	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		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
SINGULAIR	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Prescription	Yes	AB	021409	ORGANON

Top