Application Nr Approved Date Route Status External Links
ANDA078938 2010-04-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tamsulosin Hydrochloride Capsules Are Indicated For The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia (bph) [see Clinical Studies (14)]. Tamsulosin Hydrochloride Capsules Are Not Indicated For The Treatment Of Hypertension. •tamsulosin Hydrochloride Is An Alpha1 Adrenoceptor Antagonist Indicated For Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia (1) •tamsulosin Hydrochloride Capsules Are Not Indicated For The Treatment Of Hypertension (1)

All Formulated Excipients (12 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. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
4. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
6. Gelatin GELATIN Unresolved
7. Shellac SHELLAC Unresolved
8. Alcohol ALCOHOL Molecular
9. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
10. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
11. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
12. Ammonia AMMONIA Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tamsulosin Hydrochloride TAMSULOSIN HYDROCHLORIDE ZINC1530694

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