Details for New Drug Application (NDA): 019050

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NDA 019050 describes SUFENTA PRESERVATIVE FREE, which is a drug marketed by Akorn and is included in one NDA. It is available from one supplier. Additional details are available on the SUFENTA PRESERVATIVE FREE profile page.

The generic ingredient in SUFENTA PRESERVATIVE FREE is sufentanil citrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.

Summary for 019050

Tradename:	SUFENTA PRESERVATIVE FREE
Applicant:	Akorn
Ingredient:	sufentanil citrate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019050

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 019050

Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, Intravenous
Narcotics

Suppliers and Packaging for NDA: 019050

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUFENTA PRESERVATIVE FREE	sufentanil citrate	INJECTABLE;INJECTION	019050	NDA	Akorn	17478-050	17478-050-01	10 AMPULE in 1 CARTON (17478-050-01) / 1 mL in 1 AMPULE
SUFENTA PRESERVATIVE FREE	sufentanil citrate	INJECTABLE;INJECTION	019050	NDA	Akorn	17478-050	17478-050-02	10 AMPULE in 1 CARTON (17478-050-02) / 2 mL in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.05MG BASE/ML
Approval Date:	May 4, 1984	TE:	AP	RLD:	Yes

Expired US Patents for NDA 019050

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akorn	SUFENTA PRESERVATIVE FREE	sufentanil citrate	INJECTABLE;INJECTION	019050-001	May 4, 1984	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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