Orange Book product · Brand (NDA)
DAUNORUBICIN HYDROCHLORIDE
DAUNORUBICIN HYDROCHLORIDE
At a glance
Jan 30, 1998
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 30, 1998
28 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
DAUNORUBICIN HYDROCHLORIDE
Strength
EQ 5MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 050731
Product number
001
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.
- —CERUBIDINEBrand (NDA)
NDA 050484 · WYETH AYERST
- 2019DAUNORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 206195 · HISUN PHARM HANGZHOU
- 2019DAUNORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 208759 · HISUN PHARM HANGZHOU
- 2001DAUNORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065034 · FRESENIUS KABI USA
- 2000DAUNORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065035 · MEITHEAL
- 1999DAUNORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065000 · FRESENIUS KABI USA
- 1998DAUNORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 064212 · TEVA PARENTERAL
- 1995CERUBIDINEGeneric (ANDA)
ANDA 064103 · HIKMA
- —CERUBIDINEGeneric (ANDA)
ANDA 061876 · SANOFI AVENTIS US
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.
