Orange Book product · Brand (NDA)
BENDAMUSTINE HYDROCHLORIDE
BENDAMUSTINE HYDROCHLORIDE
At a glance
Dec 15, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2022
3 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
BENDAMUSTINE HYDROCHLORIDE
Strength
25MG/ML (25MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 211530
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.
- 2025BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 219014 · AVYXA HOLDINGS
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 216078 · BAXTER HLTHCARE CORP
- 2022BENDAMUSTINE HYDROCHLORIDEBrand (NDA)
NDA 215033 · APOTEX
- 2022VIVIMUSTABrand (NDA)
NDA 212209 · AZURITY
- 2018BELRAPZOBrand (NDA)
NDA 205580 · EAGLE PHARMS
- 2015BENDEKABrand (NDA)
NDA 208194 · EAGLE PHARMS
- 2009TREANDABrand (NDA)
NDA 022249 · CEPHALON
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206554 · NANG KUANG PHARM CO
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204230 · APOTEX
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214739 · EUGIA PHARMA
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211001 · MEITHEAL
- 2023BENDAMUSTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204104 · PHARMOBEDIENT
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.
