Gliadel
These highlights do not include all the information needed to use GLIADEL WAFER safely and effectively. See full prescribing information for GLIADEL WAFER. GLIADEL WAFER (carmustine implant), for intracranial useInitial U.S. Approval: 1996
Approved
Approval ID
38962a55-a514-4c48-bea5-f99a8da4beec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2018
Manufacturers
FDA
Arbor Pharmaceuticals
DUNS: 781796417
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
carmustine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-050
Application NumberNDA020637
Product Classification
M
Marketing Category
C73594
G
Generic Name
carmustine
Product Specifications
Route of AdministrationINTRACAVITARY
Effective DateDecember 13, 2018
FDA Product Classification
INGREDIENTS (2)
carmustineActive
Quantity: 7.7 mg in 1 1
Code: U68WG3173Y
Classification: ACTIB
polifeprosan 20Inactive
Code: S40C40DA21
Classification: IACT