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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 NDA: 019353

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 019353

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 019353

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/ML
Approval Date:Dec 29, 1986TE:APRLD:Yes

Expired Orange Book Patents for NDA: 019353

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
alfentanil hydrochloride
INJECTABLE;INJECTION019353-001Dec 29, 19864,167,574► Subscribe
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