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FDA Approval

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

FDA Approval Summary

Effective Date
April 28, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fentanyl(0.8 mg in 1 1)

Products7

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

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Product Details

NDC Product Code
71500-016
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
April 28, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.8 mg in 1 1

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Product Details

NDC Product Code
71500-006
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
April 28, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.6 mg in 1 1

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Product Details

NDC Product Code
71500-001
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
April 28, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.1 mg in 1 1

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Product Details

NDC Product Code
71500-004
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
April 28, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.4 mg in 1 1

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Product Details

NDC Product Code
71500-008
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
April 28, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.8 mg in 1 1

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Product Details

NDC Product Code
71500-012
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
April 28, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.6 mg in 1 1

SUBSYS

Product Details

NDC Product Code
71500-002
Application Number
NDA202788
Marketing Category
NDA (C73594)
Route of Administration
SUBLINGUAL
Effective Date
April 28, 2021
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 0.2 mg in 1 1
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