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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 212086

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NDA 212086 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 212086

Tradename:	FENTANYL CITRATE
Applicant:	Fresenius Kabi Usa
Ingredient:	fentanyl citrate
Patents:	0

Pharmacology for NDA: 212086

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 212086

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	212086	ANDA	Fresenius Kabi USA, LLC	63323-808	63323-808-11	10 SYRINGE in 1 CARTON (63323-808-11) / 1 mL in 1 SYRINGE (63323-808-01)
FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	212086	ANDA	Fresenius Kabi USA, LLC	63323-810	63323-810-20	20 SYRINGE in 1 CARTON (63323-810-20) / 2 mL in 1 SYRINGE (63323-810-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.05MG BASE/ML
Approval Date:	Sep 1, 2020	TE:	AP	RLD:	No

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