Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213471
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE;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
02/18/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

MONTELUKAST SODIUM

GRANULE;ORAL; EQ 4MG BASE/PACKET
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/PACKET GRANULE;ORAL Prescription No AB 203438 AJANTA PHARMA LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE;ORAL Prescription No AB 213471 AUROBINDO PHARMA LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE;ORAL Prescription No AB 202906 DR REDDYS LABS LTD
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE;ORAL Prescription No AB 090955 TEVA PHARMS
MONTELUKAST SODIUM MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE;ORAL Prescription No AB 210431 TORRENT
SINGULAIR MONTELUKAST SODIUM EQ 4MG BASE/PACKET GRANULE;ORAL Prescription Yes AB 021409 MERCK

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