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Last Updated: December 28, 2024

Details for New Drug Application (NDA): 077062

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NDA 077062 describes FENTANYL-75, which is a drug marketed by Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, and Zydus Pharms, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FENTANYL-75 profile page.

The generic ingredient in FENTANYL-75 is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for 077062

Tradename:	FENTANYL-75
Applicant:	Mayne Pharma
Ingredient:	fentanyl
Patents:	0

Medical Subject Heading (MeSH) Categories for 077062

Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, Intravenous
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	25MCG/HR
Approval Date:	Aug 20, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	50MCG/HR
Approval Date:	Aug 20, 2007	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	75MCG/HR
Approval Date:	Aug 20, 2007	TE:		RLD:	No

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