Orange Book product · Generic (ANDA)
MONTELUKAST SODIUM
MONTELUKAST SODIUM
At a glance
Jul 31, 2015
Approved
Generic (ANDA)
Application
AB
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/PACKET
Dosage form
GRANULE
Route
ORAL
TE code
AB
Application
ANDA 203438
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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.
