Orange Book product · Generic (ANDA)
PALONOSETRON HYDROCHLORIDE
PALONOSETRON HYDROCHLORIDE
At a glance
Jun 29, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 29, 2021
5 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
PALONOSETRON HYDROCHLORIDE
Strength
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 202951
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PALONOSETRON HYDROCHLORIDE
- 2017PALONOSETRON HYDROCHLORIDEBrand (NDA)
NDA 208109 · FRESENIUS KABI USA
- 2016PALONOSETRON HYDROCHLORIDEBrand (NDA)
NDA 207963 · HIKMA
- 2016POSFREABrand (NDA)
NDA 203050 · AVYXA HOLDINGS
- 2008ALOXIBrand (NDA)
NDA 022233 · HELSINN HLTHCARE
- 2008ALOXIBrand (NDA)
NDA 021372 · HELSINN HLTHCARE
- 2023PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 215861 · MEITHEAL
- 2021PALONOSETRON HYDROCHLORIDEGeneric (ANDA)
ANDA 206916 · BAXTER HLTHCARE CORP
- 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.
