Application Nr Approved Date Route Status External Links
NDA050689 1992-12-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Mycobutin Capsules Are Indicated For The Prevention Of Disseminated Mycobacterium Avium Complex (mac) Disease In Patients With Advanced Hiv Infection.

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. 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.
3. Ferric Oxide Red FERRIC OXIDE RED Unresolved
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
5. 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.
6. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Rifabutin RIFABUTIN ZINC169358749

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