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Generated: December 15, 2018

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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. Three 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 ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 019050
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, Inc. 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, Inc. 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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:May 4, 1984TE:APRLD:Yes

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