Details for New Drug Application (NDA): 215870

NDA 215870 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 seven 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 215870

Tradename:	FENTANYL CITRATE
Applicant:	Exela Pharma
Ingredient:	fentanyl citrate
Patents:	0

Pharmacology for NDA: 215870

Mechanism of Action

Full Opioid Agonists

Suppliers and Packaging for NDA: 215870

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENTANYL CITRATE	fentanyl citrate	SOLUTION;INTRAVENOUS	215870	NDA	Exela Pharma Sciences, LLC	51754-2150	51754-2150-4	25 VIAL in 1 CARTON (51754-2150-4) / 50 mL in 1 VIAL (51754-2150-1)
FENTANYL CITRATE	fentanyl citrate	SOLUTION;INTRAVENOUS	215870	NDA	Exela Pharma Sciences, LLC	51754-2160	51754-2160-4	25 VIAL in 1 CARTON (51754-2160-4) / 100 mL in 1 VIAL (51754-2160-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 2.5MG BASE/50ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 8, 2023	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 8, 2023	TE:		RLD:	Yes

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