OXYBUTYNIN CHLORIDE EXTENDED RELEASE- oxybutynin chloride tablet, extended release

Active ingredient:

OXYBUTYNIN CHLORIDE (UNII: L9F3D9RENQ) (OXYBUTYNIN - UNII:K9P6MC7092)

Available from:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

OXYBUTYNIN CHLORIDE

Composition:

OXYBUTYNIN CHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. Oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. There have been reports of hypersensitivity reactions, including anaphylaxis and angiodema. Pregnancy Category B. There are no adequate and well-controlled studies using Oxybutynin chloride extended-releas

Product summary:

Oxybutynin chloride extended-release tablets 5 mg are round, biconvex, white coated tablets imprinted in black ink with "270" on one side and "KU" on the other side. They are supplied as follows: Bottles of 30 Tablets               NDC 62175-270-32 Bottles of 100 Tablets             NDC 62175-270-37 Bottles of 500 Tablets             NDC 62175-270-41 Bottles of 1000 Tablets           NDC 62175-270-43 Oxybutynin chloride extended-release tablets 10 mg are round, biconvex, white coated tablets imprinted in black ink with "271" on one side and "KU" on the other side. They are supplied as follows: Bottles of 30 Tablets               NDC 62175-271-32 Bottles of 100 Tablets             NDC 62175-271-37 Bottles of 500 Tablets             NDC 62175-271-41 Bottles of 1000 Tablets           NDC 62175-271-43 Oxybutynin chloride extended-release tablets 15 mg are round, biconvex, white coated tablets imprinted in black ink with "272" on one side and "KU" on the other side. They are supplied as follows: Bottles of 30 Tablets               NDC 62175-272-32 Bottles of 100 Tablets             NDC 62175-272-37 Bottles of 500 Tablets             NDC 62175-272-41 Bottles of 1000 Tablets           NDC 62175-272-43 Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.

Authorization status:

Abbreviated New Drug Application