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

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

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
3. Anhydrous Dextrose ANHYDROUS DEXTROSE Molecular
4. Tartaric Acid TARTARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
5. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
6. 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.
7. Cellulose Acetate CELLULOSE ACETATE Unresolved
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
11. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
12. 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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