Orange Book product · Generic (ANDA)
RILUZOLE
RILUZOLE
At a glance
Aug 22, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2024
1 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
RILUZOLE
Strength
50MG/10ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 216035
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RILUZOLE
- 2019EXSERVANBrand (NDA)
NDA 212640 · AQUESTIVE
- 2018TIGLUTIK KITBrand (NDA)
NDA 209080 · ITALFARMACO SA
- 1995RILUTEKBrand (NDA)
NDA 020599 · AZURITY
- 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.
