Application Nr Approved Date Route Status External Links
ANDA076702 2006-11-09 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Oxybutynin Chloride Is A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency, And Frequency. Oxybutynin Chloride Extended-Release Tablets, Usp Are Also Indicated For The Treatment Of Pediatric Patients Aged 6 Years And Older With Symptoms Of Detrusor Overactivity Associated With A Neurological Condition (e.g., Spina Bifida). •oxybutynin Chloride Is A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency, And Frequency. (1) •oxybutynin Chloride Extended-Release Tablets, Usp Are Also Indicated For The Treatment Of Pediatric Patients Aged 6 Years And Older With Symptoms Of Detrusor Overactivity Associated With A Neurological Condition (e.g., Spina Bifida). (1)

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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