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Last Updated: November 21, 2019

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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. It is available from three suppliers. 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. Eleven 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
Pharmacology for NDA: 019813
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 019813
Suppliers and Packaging for NDA: 019813
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 NDA Sandoz,Inc. 0781-7240 0781-7240-55 5 POUCH in 1 BOX (0781-7240-55) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813 NDA Sandoz,Inc. 0781-7241 0781-7241-55 5 POUCH in 1 BOX (0781-7241-55) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH
Paragraph IV (Patent) Challenges for 019813
Tradename Dosage Ingredient NDA Submissiondate
DURAGESIC-37 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-100 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-50 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-12 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-75 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-25 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength100MCG/HR
Approval Date:Aug 7, 1990TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength75MCG/HR
Approval Date:Aug 7, 1990TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength50MCG/HR
Approval Date:Aug 7, 1990TE:ABRLD:Yes

Expired US Patents for NDA 019813

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

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