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)