Orange Book product · Brand (NDA)
EXSERVAN
RILUZOLE
At a glance
Nov 22, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2019
6 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
RILUZOLE
Strength
50MG
Dosage form
FILM
Route
ORAL
TE code
Not listed
Application
NDA 212640
Product number
001
Marketing status
DISCN
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.
- 2018TIGLUTIK KITBrand (NDA)
NDA 209080 · ITALFARMACO SA
- 1995RILUTEKBrand (NDA)
NDA 020599 · AZURITY
- 2024RILUZOLEGeneric (ANDA)
ANDA 216035 · ALKEM LABS LTD
- 2019RILUZOLEGeneric (ANDA)
ANDA 206045 · KENTON
- 2018RILUZOLEGeneric (ANDA)
ANDA 204430 · DAITO PHARMS CO LTD
- 2016RILUZOLEGeneric (ANDA)
ANDA 204048 · ALKEM LABS LTD
- 2013RILUZOLEGeneric (ANDA)
ANDA 203042 · PHARMOBEDIENT
- 2013RILUZOLEGeneric (ANDA)
ANDA 091300 · APOTEX CORP
- 2013RILUZOLEGeneric (ANDA)
ANDA 091394 · GLENMARK PHARMS LTD
- 2013RILUZOLEGeneric (ANDA)
ANDA 091417 · SUN PHARM INDS LTD
- 2003RILUZOLEGeneric (ANDA)
ANDA 076173 · IMPAX LABS
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.
