Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020195

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NDA 020195 describes FENTANYL, which is a drug marketed by Cephalon, Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, Dr Reddys, Actavis Labs Ut Inc, Difgen Pharms, Kindeva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, and Zydus Pharms, and is included in twenty-nine NDAs. Additional details are available on the FENTANYL profile page.

The generic ingredient in FENTANYL is fentanyl. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Summary for 020195

Tradename:	FENTANYL
Applicant:	Cephalon
Ingredient:	fentanyl citrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 0.2MG BASE
Approval Date:	Oct 4, 1993	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 0.3MG BASE
Approval Date:	Oct 4, 1993	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TROCHE/LOZENGE;ORAL			Strength	EQ 0.4MG BASE
Approval Date:	Oct 4, 1993	TE:		RLD:	No

Expired US Patents for NDA 020195

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-001	Oct 4, 1993	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-007	Oct 30, 1995	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-003	Oct 4, 1993	⤷ Start Trial	⤷ Start Trial
Cephalon	FENTANYL	fentanyl citrate	TROCHE/LOZENGE;ORAL	020195-002	Oct 4, 1993	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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