Application Nr Approved Date Route Status External Links
ANDA204010 2015-11-23 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, Usp 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, 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 Extended Release Tablets, Usp 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, 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 (7 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE 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. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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