Details for New Drug Application (NDA): 019353

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NDA 019353 describes ALFENTA, which is a drug marketed by Rising and Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the ALFENTA profile page.

The generic ingredient in ALFENTA is alfentanil hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alfentanil hydrochloride profile page.

Summary for 019353

Tradename:	ALFENTA
Applicant:	Rising
Ingredient:	alfentanil hydrochloride
Patents:	0

Pharmacology for NDA: 019353

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 019353

Analgesics, Opioid
Anesthetics, Intravenous
Narcotics

Suppliers and Packaging for NDA: 019353

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353	NDA	Akorn	17478-067	17478-067-02	10 AMPULE in 1 CARTON (17478-067-02) / 2 mL in 1 AMPULE
ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353	NDA	Akorn	17478-067	17478-067-05	10 AMPULE in 1 CARTON (17478-067-05) / 5 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.5MG BASE/ML
Approval Date:	Dec 29, 1986	TE:	AP	RLD:	Yes

Expired US Patents for NDA 019353

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	ALFENTA	alfentanil hydrochloride	INJECTABLE;INJECTION	019353-001	Dec 29, 1986	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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