Application Nr Approved Date Route Status External Links
NDA020897 1999-06-22 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ditropan Xl® (oxybutynin Chloride) Is A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency, And Frequency. Ditropan Xl® Is 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). Ditropan Xl® (oxybutynin Chloride) Is A Muscarinic Antagonist Indicated For The Treatment Of Overactive Bladder With Symptoms Of Urge Urinary Incontinence, Urgency, And Frequency. (1) Ditropan Xl® Is 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 (8 Total)

Name Structure Kind Function Status
1. Cellulose Acetate CELLULOSE ACETATE Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose, Unspecified Form LACTOSE, UNSPECIFIED FORM Molecular
4. 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.
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. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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