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
f969e2bc-6297-4e29-89d3-a3685a2c7c6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2014
Manufacturers
FDA
Galena Biopharma, Inc.
DUNS: 044320456
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fentanyl citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57881-338
Application NumberNDA022510
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 30, 2014
FDA Product Classification
INGREDIENTS (5)
fentanyl citrateActive
Quantity: 800 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
fentanyl citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57881-333
Application NumberNDA022510
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 30, 2014
FDA Product Classification
INGREDIENTS (5)
fentanyl citrateActive
Quantity: 300 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
fentanyl citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57881-331
Application NumberNDA022510
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 30, 2014
FDA Product Classification
INGREDIENTS (5)
fentanyl citrateActive
Quantity: 100 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
fentanyl citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57881-336
Application NumberNDA022510
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 30, 2014
FDA Product Classification
INGREDIENTS (5)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
fentanyl citrateActive
Quantity: 600 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
fentanyl citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57881-334
Application NumberNDA022510
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 30, 2014
FDA Product Classification
INGREDIENTS (5)
fentanyl citrateActive
Quantity: 400 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
fentanyl citrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57881-332
Application NumberNDA022510
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 30, 2014
FDA Product Classification
INGREDIENTS (5)
fentanyl citrateActive
Quantity: 200 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT