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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Johnson and Johnson
Deloitte
Colorcon
Fuji
Healthtrust
US Army
Cerilliant
AstraZeneca

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077312

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NDA 077312 describes FENTANYL CITRATE, which is a drug marketed by Abbott, Hospira, Watson Labs, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, Watson Labs Inc, and West-ward Pharms Int, and is included in fifteen NDAs. It is available from four 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 077312
Tradename:FENTANYL CITRATE
Applicant:Par Pharm
Ingredient:fentanyl citrate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 077312
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 077312
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312 ANDA Par Pharmaceutical Inc. 49884-459 N 49884-459-55
FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 077312 ANDA Par Pharmaceutical Inc. 49884-460 N 49884-460-55

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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US Department of Justice
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Harvard Business School
Daiichi Sankyo
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Fish and Richardson

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