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Generated: April 24, 2017

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Details for New Drug Application (NDA): 019115

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NDA 019115 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: 019115

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 019115

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 019115

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fentanyl citrate
INJECTABLE;INJECTION 019115 NDA Hospira, Inc. 0409-9093 0409-9093-11 10 AMPULE in 1 CELLO PACK (0409-9093-11) > 2 mL in 1 AMPULE (0409-9093-09)
fentanyl citrate
INJECTABLE;INJECTION 019115 NDA Hospira, Inc. 0409-9093 0409-9093-32 10 AMPULE in 1 CELLO PACK (0409-9093-32) > 2 mL in 1 AMPULE (0409-9093-37)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Jan 12, 1985TE:APRLD:No

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