Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203328
Company: AJANTA PHARMA LTD
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
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-10 Labeling-Package Insert

Label is not available on this site.

11/08/2019 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

11/08/2019 SUPPL-7 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.

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 209011 ADAPTIS
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 203328 AJANTA PHARMA LTD
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 CIPLA
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 091128 HIKMA
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 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 MSD MERCK CO

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 209011 ADAPTIS
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 203328 AJANTA PHARMA LTD
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 CIPLA
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 091128 HIKMA
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 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 MSD MERCK CO

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