bicalutamide
bicalutamide is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including bicalutamide. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- bicalutamide
- Brand Names
- bicalutamide
- Application Number
- ANDA079110
- Sponsor
- Proficient Rx LP
- NDC Codes
- 2
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- BICALUTAMIDE
Indications and Usage
1. INDICATIONS AND USAGE Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. ( 1 ) Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. ( 1 )