Application Nr Approved Date Route Status External Links
ANDA079110 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bicalutamide Tablets, Usp 50 Mg Daily Are 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, Usp 150 Mg Daily Are Not Approved For Use Alone Or With Other Treatments [See Clinical Studies (14.2)]. Bicalutamide Tablet 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 Tablet 150 Mg Daily Is Not Approved For Use Alone Or With Other Treatments. (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Bicalutamide BICALUTAMIDE ZINC538564

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