Application Nr Approved Date Route Status External Links
ANDA076644 2007-05-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Oxybutynin Chloride Extended-Release Tablets Are Once Daily Controlled-Release Tablets Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency, And Frequency. Pediatric Use Information For The Treatment Of Patients Aged 6 Years And Older With Symptoms Of Detrusor Overactivity Associated With A Neurological Condition (e.g., Spina Bifida) Is Approved For Alza Corporation’s Oxybutynin Extended-Release Tablets. However, Due To Alza Corporation’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled For Pediatric Use.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES 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. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
7. Povidones POVIDONES Unresolved
8. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Oxybutynin Chloride OXYBUTYNIN CHLORIDE ZINC1530751

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