BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
McKesson
US Army
Cipla
Novartis
Healthtrust
Harvard Business School
AstraZeneca
Fish and Richardson

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079075

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NDA 079075 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 079075
Tradename:FENTANYL CITRATE
Applicant:Watson Labs
Ingredient:fentanyl citrate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 079075
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 079075
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENTANYL CITRATE fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 079075 ANDA Actavis Pharma, Inc. 0591-3571 0591-3571-96 7 BLISTER PACK in 1 CARTON (0591-3571-96) > 4 TABLET in 1 BLISTER PACK (0591-3571-04)
FENTANYL CITRATE fentanyl citrate TABLET;BUCCAL, SUBLINGUAL 079075 ANDA Actavis Pharma, Inc. 0591-3572 0591-3572-96 7 BLISTER PACK in 1 CARTON (0591-3572-96) > 4 TABLET in 1 BLISTER PACK (0591-3572-04)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.1MG BASE
Approval Date:Jan 7, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.2MG BASE
Approval Date:Jan 7, 2011TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;BUCCAL, SUBLINGUALStrengthEQ 0.4MG BASE
Approval Date:Jan 7, 2011TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
Argus Health
Chubb
Dow
Teva
QuintilesIMS
Express Scripts
Citi
Harvard Business School

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