Orange Book product · Brand (NDA)
RISPERDAL
RISPERIDONE
At a glance
Apr 02, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 2003
23 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
RISPERIDONE
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 021444
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.
- 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
- 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
- 2015RISPERIDONEGeneric (ANDA)
ANDA 202386 · CHARTWELL MOLECULAR
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.
