Orange Book product · Brand (NDA)
IDAMYCIN PFS
IDARUBICIN HYDROCHLORIDE
At a glance
Feb 17, 1997
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 17, 1997
29 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
IDARUBICIN HYDROCHLORIDE
Strength
5MG/5ML (1MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 050734
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1990IDAMYCINBrand (NDA)
NDA 050661 · 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.
