Orange Book product · Generic (ANDA)
MONTELUKAST SODIUM
MONTELUKAST SODIUM
At a glance
Jul 31, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 31, 2015
11 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
MONTELUKAST SODIUM
Strength
EQ 4MG BASE
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
ANDA 203328
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MONTELUKAST SODIUM
- 2002SINGULAIRBrand (NDA)
NDA 021409 · ORGANON
- 2000SINGULAIRBrand (NDA)
NDA 020830 · ORGANON
- 2020MONTELUKAST SODIUMGeneric (ANDA)
ANDA 205319 · BRECKENRIDGE
- 2020MONTELUKAST SODIUMGeneric (ANDA)
ANDA 205107 · AMNEAL PHARMS
- 2020MONTELUKAST SODIUMGeneric (ANDA)
ANDA 213471 · AUROBINDO PHARMA LTD
- 2018MONTELUKAST SODIUMGeneric (ANDA)
ANDA 207464 · CHARTWELL MOLECULAR
- 2018MONTELUKAST SODIUMGeneric (ANDA)
ANDA 210431 · TORRENT
- 2018MONTELUKAST SODIUMGeneric (ANDA)
ANDA 208621 · UNICHEM
- 2017MONTELUKAST SODIUMGeneric (ANDA)
ANDA 206112 · L PERRIGO CO
- 2017MONTELUKAST SODIUMGeneric (ANDA)
ANDA 209012 · RISING
- 2017MONTELUKAST SODIUMGeneric (ANDA)
ANDA 209011 · RISING
- 2016MONTELUKAST SODIUMGeneric (ANDA)
ANDA 207463 · CIPLA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
