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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 | Doxil (doxorubicin HCl liposome) injection, Johnson & Johnson Pharma, Efficacy Supplement with Clinical Data to Support | Doxil (doxorubicin HCl liposome injection), Alza Corp, Accelerated Approval | Doxil (Doxorubicin HCI Liposomal Injection), Alza Corp., Accelerated Approval | Doxil (doxorubicin HCI ) Liposome Injection, Alza Corp., Labeling Revision & New or Modified Indication | DOXIL (doxorubicin hydrochloride) Injection, Alza Corp., Accelerated Approval | Adriamycin PFS (doxorubicin hydrochloride) Injection, Pfizer, Inc., Labeling Revision | Adriamycin RDF (doxorubicin hydrochloride) Injection, Pfizer, Inc., Labeling Revision | Doxorubicin Hydrochloride Injection, Onco Therapies Limited, Approval
  
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