Orange Book product · Generic (ANDA)
IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE
At a glance
Mar 29, 2011
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 2011
15 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
IDARUBICIN HYDROCHLORIDE
Strength
5MG/5ML (1MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 091293
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IDARUBICIN HYDROCHLORIDE
- 1997IDAMYCIN PFSBrand (NDA)
NDA 050734 · PFIZER
- 1990IDAMYCINBrand (NDA)
NDA 050661 · PFIZER
- 2012IDARUBICIN HYDROCHLORIDEGeneric (ANDA)
ANDA 200144 · RISING
- 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.
