Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pharmaceutics International, Inc.
Galena Biopharma, Inc.
878265586
Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Abstral
Product Details
NDC Product Code
57881-338Application Number
NDA022510Marketing Category
NDA (C73594)Route of Administration
SUBLINGUALEffective Date
November 30, 2014FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 800 ug in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
Abstral
Product Details
NDC Product Code
57881-333Application Number
NDA022510Marketing Category
NDA (C73594)Route of Administration
SUBLINGUALEffective Date
November 30, 2014FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 300 ug in 1 1
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
Abstral
Product Details
NDC Product Code
57881-331Application Number
NDA022510Marketing Category
NDA (C73594)Route of Administration
SUBLINGUALEffective Date
November 30, 2014FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 100 ug in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
Abstral
Product Details
NDC Product Code
57881-336Application Number
NDA022510Marketing Category
NDA (C73594)Route of Administration
SUBLINGUALEffective Date
November 30, 2014magnesium stearateInactive
Code: 70097M6I30Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 600 ug in 1 1
Abstral
Product Details
NDC Product Code
57881-334Application Number
NDA022510Marketing Category
NDA (C73594)Route of Administration
SUBLINGUALEffective Date
November 30, 2014FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 400 ug in 1 1
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
Abstral
Product Details
NDC Product Code
57881-332Application Number
NDA022510Marketing Category
NDA (C73594)Route of Administration
SUBLINGUALEffective Date
November 30, 2014FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 200 ug in 1 1
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
mannitolInactive
Code: 3OWL53L36AClass: IACT