Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202468
Company: AUROBINDO PHARMA LTD
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
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/2012/202468Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/23/2018 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

12/08/2015 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

12/08/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/04/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

12/13/2012 SUPPL-4 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

12/13/2012 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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 203432 AJANTA PHARMA LTD
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 207463 CIPLA
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 209012 CSPC OUYI
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 GENERICS
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 206112 L PERRIGO CO
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 201522 LANNETT CO INC
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 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 LABS LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 202859 UNIMARK REMEDIES LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 10MG BASE TABLET;ORAL Prescription No AB 090655 WEST-WARD PHARMS INT
SINGULAIR MONTELUKAST SODIUM EQ 10MG BASE TABLET;ORAL Prescription Yes AB 020829 MSD MERCK CO

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