Orange Book product · Generic (ANDA)
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE
At a glance
Mar 17, 1989
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 1989
37 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DOXORUBICIN HYDROCHLORIDE
Strength
10MG/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 062921
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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
- 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
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.
