Application Nr Approved Date Route Status External Links
ANDA075780 2001-09-19 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Flutamide Capsules Are Indicated For Use In Combination With Lhrh Agonists For The Management Of Locally Confined Stage B2-C And Stage D2 Metastatic Carcinoma Of The Prostate. Stage B2-C Prostatic Carcinoma Treatment With Flutamide Capsules And The Goserelin Acetate Implant Should Start 8 Weeks Prior To Initiating Radiation Therapy And Continue During Radiation Therapy. Stage D2 Metastatic Carcinoma To Achieve Benefit From Treatment, Flutamide Capsules Should Be Initiated With The Lhrh Agonist And Continued Until Progression.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Starch, Corn STARCH, CORN Unresolved
3. Gelatin GELATIN Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
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. Flutamide FLUTAMIDE ZINC3812944