Details for New Drug Application (NDA): 020747

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NDA 020747 describes ACTIQ, which is a drug marketed by Cephalon and is included in one NDA. It is available from two suppliers. Additional details are available on the ACTIQ profile page.

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

Summary for 020747

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

Pharmacology for NDA: 020747

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 020747

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-7865	0093-7865-65	30 BLISTER PACK in 1 CARTON (0093-7865-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7865-19)
ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-7866	0093-7866-65	30 BLISTER PACK in 1 CARTON (0093-7866-65) / 1 LOZENGE in 1 BLISTER PACK (0093-7866-19)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TROCHE/LOZENGE;TRANSMUCOSAL			Strength	EQ 0.2MG BASE
Approval Date:	Nov 4, 1998	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TROCHE/LOZENGE;TRANSMUCOSAL			Strength	EQ 0.4MG BASE
Approval Date:	Nov 4, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TROCHE/LOZENGE;TRANSMUCOSAL			Strength	EQ 0.6MG BASE
Approval Date:	Nov 4, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020747

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998	⤷ Sign Up	⤷ Sign Up
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-004	Nov 4, 1998	⤷ Sign Up	⤷ Sign Up
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998	⤷ Sign Up	⤷ Sign Up
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-006	Nov 4, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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