Orange Book product · Brand (NDA)
IDAMYCIN
IDARUBICIN HYDROCHLORIDE
At a glance
Sep 27, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 1990
36 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
IDARUBICIN HYDROCHLORIDE
Strength
5MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 050661
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1997IDAMYCIN PFSBrand (NDA)
NDA 050734 · PFIZER
- 2012IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 200144 · RISING
- 2011IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 091293 · SANDOZ
- 2009IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065440 · FRESENIUS KABI USA
- 2007IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065288 · HIKMA
- 2006IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065275 · HIKMA
- 2002IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065037 · TEVA PARENTERAL
- 2002IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 065036 · MEITHEAL
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.
