Application Nr Approved Date Route Status External Links
ANDA078503 2009-02-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Oxybutynin Chloride Extended-Release Tablets Are A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency, And Frequency. Oxybutynin Chloride Extended-Release Tablets 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 Extended-Release Tablets Are 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 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 (11 Total)

Name Structure Kind Function Status
1. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
2. Dextrose, Unspecified Form DEXTROSE, UNSPECIFIED FORM Molecular
3. Tartaric Acid TARTARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
5. 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.
6. Cellulose Acetate CELLULOSE ACETATE Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
9. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
10. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
11. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

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

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