Orange Book product · Brand (NDA)
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DOXORUBICIN HYDROCHLORIDE
Strength
50MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 050467
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1995DOXIL (LIPOSOMAL)Brand (NDA)
NDA 050718 · BAXTER HLTHCARE CORP
- 1987DOXORUBICIN HYDROCHLORIDEBrand (NDA)
NDA 050629 · PFIZER
- 2026DOXORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 219881 · QILU PHARM HAINAN
- 2025DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Generic (ANDA)
ANDA 219199 · ALEMBIC
- 2024DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Generic (ANDA)
ANDA 215178 · LUPIN
- 2022DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Generic (ANDA)
ANDA 212219 · BAXTER HLTHCARE CORP
- 2021DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Generic (ANDA)
ANDA 207228 · AYANA PHARMA LTD
- 2020DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Generic (ANDA)
ANDA 212299 · ZYDUS LIFESCIENCES
- 2019DOXORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 206062 · HISUN PHARM HANGZHOU
- 2017DOXORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 209825 · GLAND
- 2017DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)Generic (ANDA)
ANDA 208657 · DR REDDYS
- 2017DOXORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208888 · AMNEAL
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.
