Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203438
Company: AJANTA PHARMA LTD

Products on ANDA 203438

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 203438

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2015	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
10/20/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/08/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
11/08/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/08/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203438

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