Orange Book product · Generic (ANDA)
PALONOSETRON HYDROCHLORIDE
PALONOSETRON HYDROCHLORIDE
At a glance
Sep 19, 2018
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
PALONOSETRON HYDROCHLORIDE
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 206416
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
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 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
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.
