Orange Book product · Generic (ANDA)
RISPERIDONE
RISPERIDONE
At a glance
Dec 22, 2009
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2009
16 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
RISPERIDONE
Strength
0.5MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
AB
Application
ANDA 078116
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of RISPERIDONE
- 2024RISVANBrand (NDA)
NDA 214835 · LABS FARMS ROVI SA
- 2023UZEDYBrand (NDA)
NDA 213586 · TEVA
- 2023RYKINDOBrand (NDA)
NDA 212849 · SHANDONG LUYE
- 2018PERSERIS KITBrand (NDA)
NDA 210655 · INDIVIOR
- 2007RISPERDAL CONSTABrand (NDA)
NDA 021346 · JANSSEN PHARMS
- 2003RISPERDALBrand (NDA)
NDA 021444 · JANSSEN PHARMS
- 1999RISPERDALBrand (NDA)
NDA 020272 · JANSSEN PHARMS
- 1996RISPERDALBrand (NDA)
NDA 020588 · JANSSEN PHARMS
- 2025RISPERIDONEGeneric (ANDA)
ANDA 218586 · AMNEAL
- 2025RISPERIDONEGeneric (ANDA)
ANDA 211220 · NANOMI
- 2024RISPERIDONEGeneric (ANDA)
ANDA 205104 · IPCA LABS LTD
- 2023RISPERIDONEGeneric (ANDA)
ANDA 214068 · TEVA PHARMS USA INC
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.
