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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 019813


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NDA 019813 describes DURAGESIC-75, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the DURAGESIC-75 profile page.

The generic ingredient in DURAGESIC-75 is fentanyl. There are thirty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 019813
Tradename:DURAGESIC-75
Applicant:Janssen Pharms
Ingredient:fentanyl
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019813

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 7, 1990TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength75MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 7, 1990TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 7, 1990TE:RLD:Yes

Expired US Patents for NDA 019813

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms DURAGESIC-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-003 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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