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Generated: February 15, 2019

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Details for New Drug Application (NDA): 019353

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NDA 019353 describes ALFENTA, which is a drug marketed by Akorn 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. Two suppliers are listed for this compound. Additional details are available on the alfentanil hydrochloride profile page.
Summary for 019353
Ingredient:alfentanil hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 019353
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 019353
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, Inc. 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, Inc. 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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Dec 29, 1986TE:APRLD:Yes

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