MedPath
FDA Approval

SUBSYS

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

FDA Approval Summary

Company
Effective Date
May 4, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fentanyl(0.4 mg in 1 1)

Products7

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

SUBSYS

Product Details

NDC Product Code
20482-004
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
May 4, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.4 mg in 1 1

SUBSYS

Product Details

NDC Product Code
20482-008
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
May 4, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.8 mg in 1 1

SUBSYS

Product Details

NDC Product Code
20482-016
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
May 4, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.8 mg in 1 1

SUBSYS

Product Details

NDC Product Code
20482-006
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
May 4, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.6 mg in 1 1

SUBSYS

Product Details

NDC Product Code
20482-001
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
May 4, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.1 mg in 1 1

SUBSYS

Product Details

NDC Product Code
20482-002
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
May 4, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.2 mg in 1 1

SUBSYS

Product Details

NDC Product Code
20482-012
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
May 4, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.6 mg in 1 1
© Copyright 2025. All Rights Reserved by MedPath