FDA Orange Book · active-ingredient family
Daunorubicin hydrochloride
Daunorubicin hydrochloride is approved as 2 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DAUNORUBICIN HYDROCHLORIDE · NDA 050731
2
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAUNORUBICIN HYDROCHLORIDERLD | HIKMA | NDA 050731 | AP | Jan 30, 1998 | |
| CERUBIDINE | WYETH AYERST | NDA 050484 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAUNORUBICIN HYDROCHLORIDE | HISUN PHARM HANGZHOU | ANDA 206195 | — | Apr 25, 2019 | |
| DAUNORUBICIN HYDROCHLORIDE | HISUN PHARM HANGZHOU | ANDA 208759 | AP | Apr 12, 2019 | |
| DAUNORUBICIN HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 065034 | — | Nov 20, 2001 | |
| DAUNORUBICIN HYDROCHLORIDE | MEITHEAL | ANDA 065035 | AP | Jan 24, 2000 | |
| DAUNORUBICIN HYDROCHLORIDE | FRESENIUS KABI USA | ANDA 065000 | AP | May 25, 1999 | |
| DAUNORUBICIN HYDROCHLORIDE×2 | TEVA PARENTERAL | ANDA 064212 | — | Jun 23, 1998 | |
| CERUBIDINE | HIKMA | ANDA 064103 | AP | Feb 03, 1995 | |
| CERUBIDINE | SANOFI AVENTIS US | ANDA 061876 | — | Approved Prior to Jan 1, 1982 |
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.
Daunorubicin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
