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FDA Approval

Fentanyl

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

FDA Approval Summary

Company
Effective Date
March 3, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fentanyl(100 ug in 1 h)

Manufacturing Establishments1

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

Dispensing Solutions Inc.

Dispensing Solutions Inc.

066070785

Products3

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

Fentanyl

Product Details

NDC Product Code
68258-3025
Application Number
ANDA077449
Marketing Category
ANDA (C73584)
Route of Administration
TRANSDERMAL
Effective Date
March 3, 2010
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 100 ug in 1 h
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT

Fentanyl

Product Details

NDC Product Code
68258-3024
Application Number
ANDA077449
Marketing Category
ANDA (C73584)
Route of Administration
TRANSDERMAL
Effective Date
March 3, 2010
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 75 ug in 1 h

Fentanyl

Product Details

NDC Product Code
68258-3023
Application Number
ANDA077449
Marketing Category
ANDA (C73584)
Route of Administration
TRANSDERMAL
Effective Date
March 3, 2010
FentanylActive
Code: UF599785JZClass: ACTIBQuantity: 25 ug in 1 h
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
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