Application Nr Approved Date Route Status External Links
ANDA079185 2009-07-06 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Bicalutamide Tablets 50 Mg Daily Are Indicated For Use In Combination Therapy With A Luteinizing Hormone-Releasing Hormone (lhrh) Analog For The Treatment Of Stage D2 Metastatic Carcinoma Of The Prostate. Bicalutamide Tablets 150 Mg Daily Are Not Approved For Use Alone Or With Other Treatments [see Clinical Studies (14.2)]. •bicalutamide Tablets 50 Mg Are An Androgen Receptor Inhibitor Indicated For Use In Combination Therapy With A Luteinizing Hormone-Releasing Hormone (lhrh) Analog For The Treatment Of Stage D2 Metastatic Carcinoma Of The Prostate. (1) •bicalutamide Tablets 150 Mg Daily Are Not Approved For Use Alone Or With Other Treatments. (1)

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Povidones POVIDONES Unresolved
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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