Orange Book product · Brand (NDA)
ALOXI
PALONOSETRON HYDROCHLORIDE
At a glance
Aug 22, 2008
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 22, 2008
18 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PALONOSETRON HYDROCHLORIDE
Strength
EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 022233
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.
- 2017PALONOSETRON HYDROCHLORIDEBrand (NDA)
NDA 208109 · FRESENIUS KABI USA
- 2016PALONOSETRON HYDROCHLORIDEBrand (NDA)
NDA 207963 · HIKMA
- 2016POSFREABrand (NDA)
NDA 203050 · AVYXA HOLDINGS
- 2008ALOXIBrand (NDA)
NDA 021372 · HELSINN HLTHCARE
- 2023PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 215861 · MEITHEAL
- 2021PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 206916 · BAXTER HLTHCARE CORP
- 2021PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 202951 · AVET LIFESCIENCES
- 2021PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 204615 · ACCORD HLTHCARE
- 2020PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 208789 · INGENUS PHARMS LLC
- 2018PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 204702 · EUGIA PHARMA
- 2018PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 209287 · CHARTWELL RX
- 2018PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 206396 · CIPLA
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.
