Details for New Drug Application (NDA): 019101

NDA 019101 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 019101

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

Pharmacology for NDA: 019101

Mechanism of Action

Full Opioid Agonists

Suppliers and Packaging for NDA: 019101

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	019101	NDA	Hikma Pharmaceuticals USA Inc.	0641-6027	0641-6027-25	25 VIAL in 1 CARTON (0641-6027-25) / 2 mL in 1 VIAL (0641-6027-01)
FENTANYL CITRATE	fentanyl citrate	INJECTABLE;INJECTION	019101	NDA	Hikma Pharmaceuticals USA Inc.	0641-6028	0641-6028-10	10 VIAL in 1 CARTON (0641-6028-10) / 5 mL in 1 VIAL (0641-6028-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.05MG BASE/ML
Approval Date:	Jul 11, 1984	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.025MG BASE/0.5ML
Approval Date:	Jan 20, 2023	TE:		RLD:	Yes

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