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FDA Approval

Dsuvia

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
AcelRx Pharmaceuticals, Inc.
DUNS: 789244774
Effective Date
December 18, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sufentanil(30 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Patheon Pharmaceuticals Inc.

AcelRx Pharmaceuticals, Inc.

005286822

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dsuvia

Product Details

NDC Product Code
61621-430
Application Number
NDA209128
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
December 18, 2023
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Code: AFE2YW0IIZClass: ACTIBQuantity: 30 ug in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
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