dasatinib
dasatinib is listed in the FDA National Drug Code directory with 49 NDC codes, marketed under brand names including Dasatinib, dasatinib, SPRYCEL. Available dosage forms: tablet, film coated, tablet, powder.
Drug Details
- Generic Name
- dasatinib
- Brand Names
- Dasatinib, dasatinib, SPRYCEL, PHYRAGO
- Application Number
- ANDA217217
- Sponsor
- BluePoint Laboratories
- NDC Codes
- 49
- Dosage Forms
- TABLET, FILM COATED, TABLET, POWDER
- Routes
- ORAL
- Active Ingredients
- DASATINIB
Indications and Usage
1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )