Application Nr Approved Date Route Status External Links
ANDA085223 1986-07-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Dicyclomine Hydrochloride Is Indicated For The Treatment Of Patients With Functional Bowel/irritable Bowel Syndrome. Dicyclomine Hydrochloride Is An Antispasmodic And Anticholinergic (antimuscarinic) Agent Indicated For The Treatment Of Functional Bowel/irritable Bowel Syndrome (1)

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. 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.
2. Gelatin GELATIN Unresolved
3. 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.
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dicyclomine Hydrochloride DICYCLOMINE HYDROCHLORIDE ZINC1530613

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