Valstar
These highlights do not include all the information needed to use VALSTAR safely and effectively. See full prescribing information for VALSTAR. VALSTAR (valrubicin) solution, for intravesical use Initial U.S. Approval: 1981
Approved
Approval ID
e96f30a0-6662-11de-8f80-0002a5d5c51b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2023
Manufacturers
FDA
Endo Pharmaceuticals Solutions Inc.
DUNS: 178074951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
valrubicin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67979-001
Application NumberNDA020892
Product Classification
M
Marketing Category
C73594
G
Generic Name
valrubicin
Product Specifications
Route of AdministrationINTRAVESICAL
Effective DateOctober 25, 2023
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
VALRUBICINActive
Quantity: 40 mg in 1 mL
Code: 2C6NUM6878
Classification: ACTIB
NITROGENInactive
Code: N762921K75
Classification: IACT