Valrubicin Intravesical Solution
These highlights do not include all the information needed to use VALRUBICIN INTRAVESICAL SOLUTION safely and effectively. See full prescribing information for VALRUBICIN INTRAVESICAL SOLUTION. VALRUBICIN intravesical solution, for intravesical use Initial U.S. Approval: 1981
Approved
Approval ID
8739ae02-e4c5-0fa2-e053-2a91aa0a1b74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 118707839
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valrubicin Intravesical Solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24201-101
Application NumberANDA206430
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valrubicin Intravesical Solution
Product Specifications
Route of AdministrationINTRAVESICAL
Effective DateJune 30, 2022
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Quantity: 0.5 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Quantity: 0.5 mL in 1 mL
Code: 6D4M1DAL6O
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
VALRUBICINActive
Quantity: 40 mg in 1 mL
Code: 2C6NUM6878
Classification: ACTIB