FDA Orange Book · active-ingredient family
Idarubicin hydrochloride
Idarubicin hydrochloride is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IDAMYCIN PFS · NDA 050734
2
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IDAMYCIN PFSRLD×3 | PFIZER | NDA 050734 | AP | Feb 17, 1997 | |
| IDAMYCIN×3 | PFIZER | NDA 050661 | — | Sep 27, 1990 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IDARUBICIN HYDROCHLORIDE×3 | RISING | ANDA 200144 | — | Oct 11, 2012 | |
| IDARUBICIN HYDROCHLORIDE×3 | SANDOZ | ANDA 091293 | — | Mar 29, 2011 | |
| IDARUBICIN HYDROCHLORIDE×3 | FRESENIUS KABI USA | ANDA 065440 | — | Aug 04, 2009 | |
| IDARUBICIN HYDROCHLORIDE×3 | HIKMA | ANDA 065288 | AP | May 15, 2007 | |
| IDARUBICIN HYDROCHLORIDE×3 | HIKMA | ANDA 065275 | AP | Dec 14, 2006 | |
| IDARUBICIN HYDROCHLORIDE×3 | TEVA PARENTERAL | ANDA 065037 | — | May 01, 2002 | |
| IDARUBICIN HYDROCHLORIDE×3 | MEITHEAL | ANDA 065036 | AP | May 01, 2002 |
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.
Idarubicin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
