Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078723
Company: TEVA PHARMS
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
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-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/01/2020 SUPPL-12 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

05/18/2018 SUPPL-11 Labeling-Package Insert, Labeling-Patient 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-Patient Package Insert, Labeling-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-Package Insert, Labeling-Patient 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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