Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090955
Company: TEVA PHARMS
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
08/03/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090955Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/08/2019 SUPPL-13 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/08/2019 SUPPL-12 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

11/08/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

04/28/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/28/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/26/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/06/2013 SUPPL-4 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/17/2012 SUPPL-2 Labeling-Patient Package Insert, Labeling-Package Insert

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

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