Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novitium Pharma LLC
Novitium Pharma LLC
080301870
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
70954-005Application Number
ANDA209823Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 24, 2021OxybutyninActive
Code: L9F3D9RENQClass: ACTIBQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT