Abstral
These highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL. ABSTRAL (fentanyl) sublingual tablets CII Initial U.S. Approval: 1968
Approved
Approval ID
4906457e-30ad-4da7-b3ac-bb9e6651a670
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 29, 2012
Manufacturers
FDA
ProStrakan, Inc.
DUNS: 014778321
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fentanyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42747-228
Application NumberNDA022510
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 21, 2011
FDA Product Classification
INGREDIENTS (5)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FENTANYL CITRATEActive
Quantity: 800 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM