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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200405
Company: LANNETT CO INC

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 Not Applicable Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200405Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/2023 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
06/26/2023 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/08/2020 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/08/2020 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
10/08/2020 SUPPL-10 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
07/23/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
06/02/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.
06/02/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
08/20/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
01/31/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
09/18/2012 SUPPL-1 Labeling-Container/Carton Labels, 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 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 CHARTWELL MOLECULAR
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 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 209011 RISING
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 ORGANON

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 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 CHARTWELL MOLECULAR
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 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 209011 RISING
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 ORGANON
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