Last Updated: June 24, 2026

Details for New Drug Application (NDA): 019115

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NDA 019115 describes FENTANYL CITRATE, which is a drug marketed by Abbott, Fresenius Kabi Usa, Hikma, Hospira, Watson Labs, Exela Pharma, Dr Reddys Labs Sa, Actavis Labs Fl Inc, Par Pharm, Specgx Llc, Astrazeneca, and Dr Reddys, and is included in nineteen 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 019115

Tradename:	FENTANYL CITRATE
Applicant:	Hospira
Ingredient:	fentanyl citrate
Patents:	0

Pharmacology for NDA: 019115

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 019115

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENTANYL CITRATE	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	fentanyl citrate	INJECTABLE;INJECTION	019115	NDA	Hospira, Inc.	0409-9094	0409-9094-22	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-22) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-9094-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.05MG BASE/ML
Approval Date:	Jan 12, 1985	TE:	AP	RLD:	No

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