Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206112
Company: L PERRIGO CO
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
04/26/2017 ORIG-1 Approval STANDARD

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English