Dsuvia
These highlights do not include all the information needed to use DSUVIA safely and effectively. See full prescribing information for DSUVIA. DSUVIA (sufentanil) sublingual tablet, CII Initial U.S. Approval: 1984
Approved
Approval ID
8b580f3d-e3b5-4086-b093-87a980631147
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
AcelRx Pharmaceuticals, Inc.
DUNS: 789244774
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sufentanil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61621-430
Application NumberNDA209128
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sufentanil
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (8)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SUFENTANILActive
Quantity: 30 ug in 1 1
Code: AFE2YW0IIZ
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT