decitabine

FDA Drug Profile — DECITABINE, decitabine, Decitabine

decitabine is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand names including DECITABINE, decitabine, Decitabine. Available dosage forms: injection, powder, lyophilized, for solution, kit.

Drug Details

Generic Name
decitabine
Brand Names
DECITABINE, decitabine, Decitabine
Application Number
ANDA212117
Sponsor
Nivagen Pharmaceuticals, Inc.
NDC Codes
9
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, KIT
Routes
INTRAVENOUS
Active Ingredients
DECITABINE

Indications and Usage

1 INDICATIONS AND USAGE Decitabine for injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine For Injection is a nucleoside metabolic inhibitor indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate2, and high-risk International Prognostic Scoring System groups