Orange Book product · Brand (NDA)
INVEGA
PALIPERIDONE
At a glance
Aug 26, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2008
18 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PALIPERIDONE
Strength
1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 021999
Product number
006
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.
- 2026PALIPERIDONEGeneric (ANDA)
ANDA 205402 · I3 PHARMS
- 2026PALIPERIDONEGeneric (ANDA)
ANDA 203279 · APOTEX
- 2025PALIPERIDONEGeneric (ANDA)
ANDA 218755 · ESKAYEF
- 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.
