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Last Updated: March 23, 2023

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

Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, Intravenous
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	100MCG/HR
Approval Date:	Aug 7, 1990	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	75MCG/HR
Approval Date:	Aug 7, 1990	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	50MCG/HR
Approval Date:	Aug 7, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019813

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

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