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Generated: November 21, 2018

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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 three 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. Fourteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 020747
Mechanism of ActionFull 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:RXDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.2MG BASE
Approval Date:Nov 4, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.4MG BASE
Approval Date:Nov 4, 1998TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.6MG BASE
Approval Date:Nov 4, 1998TE:ABRLD:Yes

Expired US Patents for NDA 020747

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-005 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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