Orange Book product · Generic (ANDA)
PALIPERIDONE
PALIPERIDONE
At a glance
Sep 04, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 04, 2025
10 mo ago
Today
Pharmaceutical detail
Active ingredient
PALIPERIDONE
Strength
1.5MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 218755
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PALIPERIDONE
- 2008INVEGABrand (NDA)
NDA 021999 · JANSSEN PHARMS
- 2026PALIPERIDONEGeneric (ANDA)
ANDA 205402 · I3 PHARMS
- 2026PALIPERIDONEGeneric (ANDA)
ANDA 203279 · APOTEX
- 2025PALIPERIDONEGeneric (ANDA)
ANDA 205559 · DR REDDYS
- 2024PALIPERIDONEGeneric (ANDA)
ANDA 217445 · ZYDUS PHARMS
- 2024PALIPERIDONEGeneric (ANDA)
ANDA 218330 · ALEMBIC
- 2024PALIPERIDONEGeneric (ANDA)
ANDA 218514 · AJANTA PHARMA LTD
- 2023PALIPERIDONEGeneric (ANDA)
ANDA 216174 · ASCENT PHARMS INC
- 2022PALIPERIDONEGeneric (ANDA)
ANDA 208643 · LUPIN
- 2020PALIPERIDONEGeneric (ANDA)
ANDA 212807 · CSPC OUYI
- 2019PALIPERIDONEGeneric (ANDA)
ANDA 204707 · AMNEAL PHARMS
- 2019PALIPERIDONEGeneric (ANDA)
ANDA 204452 · INVENTIA
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.
