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FDA Approval Activities for this Drug…
Idamycin (idarubicin hydrochloride) Injection USP, Pharmacia & Upjohn Company NDA 50-661/S-008 10/11/02 10/21/02 Idamycin (idarubicin hydrochloride) Injection USP, Pharmacia & Upjohn Company NDA 50-661/S-007 9/30/02 10/2/02 Idarubicin Hydrochloride Injection, 5 mg/Vial, 10 mg/vial & 20 mg/vial (Single Dose Vials), Gensia Sicor ANDA 65-037 5/1/02 4/9/03 Idarubicin Hydrochloride Injection, 1 mg/mL Packaged in 5 mg/5 mL, 10 mg/10 mL, 20 mg/20 mL single dose vials, Gensia Sicor ANDA 65-036 IDARUBICIN HYDROCHLORIDE Injection 10MG/VIAL IDARUBICIN HCL Gensia Sicor 065036 IDARUBICIN HYDROCHLORIDE Injection 1MG/ML IDARUBICIN HCL PFS Gensia Sicor 065037 IDARUBICIN HYDROCHLORIDE Injection 20MG/VIAL IDARUBICIN HCL Gensia Sicor 065037 IDARUBICIN HYDROCHLORIDE Injection 5MG/VIAL IDARUBICIN HCL Gensia Sicor 050734 IDARUBICIN HYDROCHLORIDE Injection 1MG/ML IDAMYCIN PFS PHARMACIA AND UPJOHN | Idarubicin Hydrochloride Injection, Bedford Labs, Approval | Idarubicin Hydrochloride Injection, APP Pharmaceuticals, LLC, Approval | Idarubicin Hydrochloride Injection, Sandoz Inc., Approval
  
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