Orange Book product · Generic (ANDA)
IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE
At a glance
May 01, 2002
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 01, 2002
24 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
IDARUBICIN HYDROCHLORIDE
Strength
5MG/5ML (1MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 065036
Product number
001
Marketing status
RX
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
- 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
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.
