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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019813

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DURAGESIC-100 (FENTANYL)
100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: DURAGESIC-100
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019813
Product Number: 001
Approval Date: Aug 7, 1990
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DURAGESIC-12 (FENTANYL)
12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: DURAGESIC-12
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019813
Product Number: 005
Approval Date: Feb 4, 2005
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DURAGESIC-25 (FENTANYL)
25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: DURAGESIC-25
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 25MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019813
Product Number: 004
Approval Date: Aug 7, 1990
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DURAGESIC-37 (FENTANYL)
37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: DURAGESIC-37
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019813
Product Number: 006
Approval Date: Jan 24, 2018
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DURAGESIC-50 (FENTANYL)
50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: DURAGESIC-50
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019813
Product Number: 003
Approval Date: Aug 7, 1990
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DURAGESIC-75 (FENTANYL)
75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL
Proprietary Name: DURAGESIC-75
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019813
Product Number: 002
Approval Date: Aug 7, 1990
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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