Orange Book product · Brand (NDA)
DOXIL (LIPOSOMAL)
DOXORUBICIN HYDROCHLORIDE
At a glance
Nov 17, 1995
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 17, 1995
31 yr ago
Today
Pharmaceutical detail
Active ingredient
DOXORUBICIN HYDROCHLORIDE
Strength
20MG/10ML (2MG/ML)
Dosage form
INJECTABLE, LIPOSOMAL
Route
INJECTION
TE code
AB
Application
NDA 050718
Product number
001
Marketing status
RX
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.
- 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
- 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.
