Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, Inc.
Aphena Pharma Solutions - Tennessee, Inc.
128385585
Kremers Urban Pharmaceuticals Inc.
Aphena Pharma Solutions - Tennessee, Inc.
006422406
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxybutynin Chloride
Product Details
NDC Product Code
43353-769Application Number
ANDA078503Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 26, 2012anhydrous lactoseInactive
Code: 3SY5LH9PMKClass: IACT
OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 10 mg in 1 1
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
anhydrous dextroseInactive
Code: 5SL0G7R0OKClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1AClass: IACT
cellulose acetateInactive
Code: 3J2P07GVB6Class: IACT
ferrosoferric oxideInactive
Code: XM0M87F357Class: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
tartaric acidInactive
Code: W4888I119HClass: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
triacetinInactive
Code: XHX3C3X673Class: IACT