Application Nr Approved Date Route Status External Links
ANDA202217 2014-08-20 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Gavilyte - H And Bisacodyl Delayed-Release Tablet, Usp Is Indicated For Cleansing Of The Colon As A Preparation For Colonoscopy In Adults. Gavilyte - H And Bisacodyl Delayed-Release Tablet, Usp Is A Combination Of Peg-3350, An Osmotic Laxative And Bisacodyl, A Stimulant Laxative, Indicated For Cleansing Of The Colon As A Preparation For Colonoscopy In Adults (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
2. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
3. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
4. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Sodium Bicarbonate SODIUM BICARBONATE Molecular MISC-Miscellaneous , SANI-Sanitizing agent REG-Food additives for which a petition has been filed and a regulation issued.
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.

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