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Details for New Drug Application (NDA): 077312

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NDA 077312 describes FENTANYL CITRATE, which is a drug marketed by Mallinckrodt, Par Pharm, Hospira, Abbott, Watson Labs, Astrazeneca, West-ward Pharms Int, and Watson Labs Inc, 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 NDA: 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 Lake Erie Medical DBA Quality Care Products LLC 35356-999 35356-999-30 30 BLISTER PACK in 1 CARTON (35356-999-30) > 1 LOZENGE in 1 BLISTER PACK
FENTANYL CITRATE
fentanyl citrate
TROCHE/LOZENGE;TRANSMUCOSAL 077312 ANDA Par Pharmaceutical Inc. 49884-459 49884-459-55 30 BLISTER PACK in 1 CARTON (49884-459-55) > 1 LOZENGE in 1 BLISTER PACK (49884-459-52)

Summary for product number 001

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

Summary for product number 002

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

Summary 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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