Application Nr Approved Date Route Status External Links
ANDA202433 2013-04-30 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 Capsules Are An Alpha 1 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 (8 Total)

Name Structure Kind Function Status
1. Calcium Stearate CALCIUM STEARATE Molecular AC-Anticaking agent , AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Ferric Oxide Red FERRIC OXIDE RED Molecular
4. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. 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.
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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