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Serving leading biopharmaceutical companies globally:

UBS
Merck
Teva
Chubb
McKesson
AstraZeneca
Mallinckrodt
Harvard Business School
US Department of Justice
Medtronic

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078907

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NDA 078907 describes FENTANYL CITRATE, which is a drug marketed by Abbott, Hospira, Watson Labs, Mallinckrodt, Par Pharm, Astrazeneca, Watson Labs Inc, and West-ward Pharms Int, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the FENTANYL CITRATE profile page.

The generic ingredient in FENTANYL CITRATE is droperidol; fentanyl citrate. There are five drug master file entries for this compound. Additional details are available on the droperidol; fentanyl citrate profile page.
Summary for 078907
Tradename:FENTANYL CITRATE
Applicant:Mallinckrodt
Ingredient:fentanyl citrate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078907
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 078907
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907 ANDA Mallinckrodt, Inc. 0406-9202 0406-9202-30 30 BLISTER PACK in 1 CARTON (0406-9202-30) > 1 LOZENGE in 1 BLISTER PACK
FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907 ANDA Mallinckrodt, Inc. 0406-9204 0406-9204-30 30 BLISTER PACK in 1 CARTON (0406-9204-30) > 1 LOZENGE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.2MG BASE
Approval Date:Oct 30, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.4MG BASE
Approval Date:Oct 30, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;TRANSMUCOSALStrengthEQ 0.6MG BASE
Approval Date:Oct 30, 2009TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Deloitte
Medtronic
Baxter
Harvard Business School
McKesson
Boehringer Ingelheim
US Army
Cipla

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