Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… ADRIAMYCIN PFS (doxorubicin hydrochloride injection), Pharmacia & Upjohn Company NDA 50-467/S-064/S-067 & 50-629/S-010/S-013 Doxil (doxorubicin HCl liposome) Injection, ALZA NDA 50-718/S-016 12/17/02 Doxil (doxorubicin HCl liposome) Injection, ALZA NDA 50-718/S-010 1/10/02 2/8/02 Doxil (doxorubicin HCl liposome) Injection, 50 mg/m2, ALZA NDA 50-718/S-006 6/28/99 6/30/99 6/30/99 Doxil Injection: treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens. Doxorubicin Hydrochloride Injection, 10, 20, 50, and 150 & 10, 20, 50, 75, 150, and 200 mg, Pharmacia & Upjohn Company NDA 50-467/S-068/S-069 & 50-629/S-014/S-016   For the latest approval information, locate this drug using this index.