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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 016619

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NDA 016619 describes SUBLIMAZE PRESERVATIVE FREE, which is a drug marketed by Rising and is included in one NDA. Additional details are available on the SUBLIMAZE PRESERVATIVE FREE profile page.

The generic ingredient in SUBLIMAZE PRESERVATIVE FREE is fentanyl citrate. 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 citrate profile page.

Summary for 016619

Tradename:	SUBLIMAZE PRESERVATIVE FREE
Applicant:	Rising
Ingredient:	fentanyl citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.05MG BASE/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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