hydroxyurea

FDA Drug Profile — Siklos

Drug Details

Generic Name
hydroxyurea
Brand Names
Siklos
Application Number
NDA208843
Sponsor
Medunik
NDC Codes
2
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
HYDROXYUREA

Indications and Usage

1 INDICATIONS AND USAGE Hydroxyurea capsules are indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules are an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. ( 1 )