doxorubicin hydrochloride

FDA Drug Profile — doxorubicin hydrochloride, DOXORUBICIN HYDROCHLORIDE, DOXIL, doxorubicin hydrochloride, Liposomal

doxorubicin hydrochloride is listed in the FDA National Drug Code directory with 23 NDC codes, marketed under brand names including doxorubicin hydrochloride, DOXORUBICIN HYDROCHLORIDE, DOXIL. Available dosage forms: injection, suspension, liposomal, injection, solution, injectable, liposomal.

Drug Details

Generic Name
doxorubicin hydrochloride
Brand Names
doxorubicin hydrochloride, DOXORUBICIN HYDROCHLORIDE, DOXIL, doxorubicin hydrochloride, Liposomal
Application Number
ANDA219199
Sponsor
BluePoint Laboratories
NDC Codes
23
Dosage Forms
INJECTION, SUSPENSION, LIPOSOMAL, INJECTION, SOLUTION, INJECTABLE, LIPOSOMAL
Routes
INTRAVENOUS, INTRAVITREAL
Active Ingredients
DOXORUBICIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Doxorubicin hydrochloride is an anthracycline topoisomerase inhibitor indicated for: Ovarian cancer: After failure of platinum-based chemotherapy (1.1). AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy (1.2). Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy (1.3). 1.1 Ovarian Cancer Doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. 1.2 AIDS-Related Kaposi's Sarcoma Doxorubicin hydrochloride liposome injection is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. 1.3 Multiple Myeloma Doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.