Orange Book product · Generic (ANDA)
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE
At a glance
Feb 03, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 03, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
DOXORUBICIN HYDROCHLORIDE
Strength
20MG/10ML (2MG/ML)
Dosage form
INJECTABLE, LIPOSOMAL
Route
INJECTION
TE code
AB
Application
ANDA 219881
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DOXORUBICIN HYDROCHLORIDE
- 1995DOXIL (LIPOSOMAL)Brand (NDA)
NDA 050718 · BAXTER HLTHCARE CORP
- 1987DOXORUBICIN HYDROCHLORIDEBrand (NDA)
NDA 050629 · PFIZER
- —DOXORUBICIN HYDROCHLORIDEBrand (NDA)
NDA 050467 · PFIZER
- 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.
