Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Daunorubicin Hydrochloride for Injection, 5 mg/ml, 4ml vials, Bedford NDA 50-731 1/30/98 1/7/99 Daunorubicin Hydrochloride for Injection, 20 mg (base)/single dose vial, Bigmar ANDA 65-000 5/25/99 5/26/99 Daunorubicin Hydrochloride for Injection, 20 mg (base)/single dose vial, Gensia Sicor ANDA 64-212 6/23/98 6/26/98 Daunorubicin Hydrochloride Injection, 5 mg (base)/mL, (packaged in 20 mg (base)/4 mL and 50 mg (base)/10 mL single-dose vials), Gensia Sicor ANDA 65-035 1/24/00 2/4/00 Daunorubicin Hydrochloride Injection, 5 mg (base)/mL, (packaged in 20 mg (base)/4 mL single-dose vials), SuperGen, ANDA 65-034 11/20/01 10/10/02 DaunoXome (daunorubicin citrate liposome injection), Gilead Sciences, NDA 50-704/S-008 DAUNORUBICIN CITRATE Injectable, Liposomal; Injection 2MG BASE/ML DAUNOXOME GILEAD 064103 DAUNORUBICIN HYDROCHLORIDE Injection 20MG BASE/VIAL CERUBIDINE Bedford 050731 DAUNORUBICIN HYDROCHLORIDE Injection 5MG BASE/ML DAUNORUBICIN HCL Bedford 065000 DAUNORUBICIN HYDROCHLORIDE Injection 20MG BASE/VIAL DAUNORUBICIN HCL BIGMAR 064212 DAUNORUBICIN HYDROCHLORIDE Injection 20MG BASE/VIAL DAUNORUBICIN HCL Gensia Sicor 064212 DAUNORUBICIN HYDROCHLORIDE Injection 50MG BASE/VIAL DAUNORUBICIN HCL Gensia Sicor 065035 DAUNORUBICIN HYDROCHLORIDE Injection 5MG BASE/ML DAUNORUBICIN HCL Gensia Sicor 065034 DAUNORUBICIN HYDROCHLORIDE Injection 5MG BASE/VIAL DAUNORUBICIN HCL SUPERGEN ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com