Application Nr Approved Date Route Status External Links
ANDA076932 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 50 Mg Daily Is 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 150 Mg Daily Is Not Approved For Use Alone Or With Other Treatments [see Clinical Studies (14.2)]. Bicalutamide 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 D2 Metastatic Carcinoma Of The Prostate. Bicalutamide 150 Mg Daily Is Not Approved For Use Alone Or With Other Treatments. (1)

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
7. Polyethylene Glycol 4000 POLYETHYLENE GLYCOL 4000 Unresolved
8. Povidones POVIDONES Unresolved
9. 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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