Orange Book product · Brand (NDA)
DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE
At a glance
May 03, 1988
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 03, 1988
38 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DOXORUBICIN HYDROCHLORIDE
Strength
200MG/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050629
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 1995DOXIL (LIPOSOMAL)Brand (NDA)
NDA 050718 · BAXTER HLTHCARE CORP
- —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.
