Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209011
Company: CSPC OUYI PHARM CO
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
04/18/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209011Orig1s000ltr.pdf

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 203328 AJANTA PHARMA LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 205695 ANBISON LAB CO LTD
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 209011 CSPC OUYI PHARM CO
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 203795 JUBILANT GENERICS
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 079142 MYLAN PHARMS INC
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 208621 UNICHEM LABS LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 203037 UNIMARK REMEDIES LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 091588 VINTAGE PHARMS LLC
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 091128 WEST-WARD PHARMS INT
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 203328 AJANTA PHARMA LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 205695 ANBISON LAB CO LTD
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 209011 CSPC OUYI PHARM CO
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 203795 JUBILANT GENERICS
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 079142 MYLAN PHARMS INC
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 208621 UNICHEM LABS LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 203037 UNIMARK REMEDIES LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 091588 VINTAGE PHARMS LLC
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE;ORAL Prescription No AB 091128 WEST-WARD PHARMS INT
SINGULAIR MONTELUKAST SODIUM EQ 5MG BASE TABLET, CHEWABLE;ORAL Prescription Yes AB 020830 MSD MERCK CO

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