Orange Book product · Generic (ANDA)
DAUNORUBICIN HYDROCHLORIDE
DAUNORUBICIN HYDROCHLORIDE
At a glance
Apr 12, 2019
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 12, 2019
7 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
DAUNORUBICIN HYDROCHLORIDE
Strength
EQ 5MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 208759
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DAUNORUBICIN HYDROCHLORIDE
- 1998DAUNORUBICIN HYDROCHLORIDEBrand (NDA)
NDA 050731 · HIKMA
- —CERUBIDINEBrand (NDA)
NDA 050484 · WYETH AYERST
- 2019DAUNORUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 206195 · 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.
