Oxybutynin chlorideextended release tablet, extended release

Repackaging information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 5 mg
30 43353-285-30
60 43353-285-53
90 43353-285-60

Store between 20-25C (68-77F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20171020JH

Ingredients and appearance - Product information

Oxybutynin chlorideextended release tablet, extended release- Oxybutynin chloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 43353-285
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Oxybutynin chloride ( UNII: L9F3D9RENQ)( Oxybutynin - UNII: K9P6MC7092 ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous lactose ( UNII: 3SY5LH9PMK)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Mannitol ( UNII: 3OWL53L36A)
Anhydrous dextrose ( UNII: 5SL0G7R0OK)
Tartaric acid ( UNII: W4888I119H)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Magnesium stearate ( UNII: 70097M6I30)
Cellulose acetate ( UNII: 3J2P07GVB6)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferrosoferric oxide ( UNII: XM0M87F357)
Propylene glycol ( UNII: 6DC9Q167V3)
Hypromellose 2208 (100 mpa.s) ( UNII: B1QE5P712K)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color white Imprint Code KU;270
Score 1 Shape ROUND
Size 7 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 43353-285-30 30 in 1 BOTTLE 2017/03/02
2 NDC: 43353-285-53 60 in 1 BOTTLE 2017/03/02
3 NDC: 43353-285-60 90 in 1 BOTTLE 2017/03/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA078503 USA 2017/03/02

Labeler - Aphena Pharma Solutions - Tennessee, LLC( 128385585)

Establishment

Name ID/FEI Business Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585 REPACK( 43353-285)

Principal display panel - 5 mg

NDC 43353-285 - Oxybutynin Chloride ER 5mg - Rx Only

IR = immediate release
The bundled term residual urine volume consists of the preferred terms residual urine volume and residual urine volume increased.
Covariate adjusted mean with missing observations set to baseline values
The difference betweenOxybutyninchloride extended-release tabletsand placebo was statistically significant.
Covariate adjusted mean with missing observations set to baseline values
Covariate adjusted mean with missing observations set to baseline values
The difference betweenOxybutynin chloride extended-release tabletsand oxybutynin fulfilled the criteria for comparable efficacy.