Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novartis Consumer Health, Inc.
ProStrakan, Inc.
129836151
Products1
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
42747-228Application Number
NDA022510Marketing Category
NDA (C73594)Route of Administration
SUBLINGUALEffective Date
January 21, 2011CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FentanylActive
Code: MUN5LYG46HClass: ACTIMQuantity: 800 ug in 1 1