Orange Book product · Brand (NDA)
RILUTEK
RILUZOLE
At a glance
Dec 12, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 1995
31 yr ago
Today
Pharmaceutical detail
Active ingredient
RILUZOLE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020599
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.
- 2019EXSERVANBrand (NDA)
NDA 212640 · AQUESTIVE
- 2018TIGLUTIK KITBrand (NDA)
NDA 209080 · ITALFARMACO SA
- 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.
