Orange Book product · Brand (NDA)
SINGULAIR
MONTELUKAST SODIUM
At a glance
Mar 03, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 03, 2000
26 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
MONTELUKAST SODIUM
Strength
EQ 4MG BASE
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
AB
Application
NDA 020830
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2002SINGULAIRBrand (NDA)
NDA 021409 · 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
- 2016MONTELUKAST SODIUMGeneric (ANDA)
ANDA 205683 · ANBISON LAB
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.
