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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald
Daiichi Sankyo
Farmers Insurance

Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074534

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NDA 074534 describes SUFENTANIL CITRATE, which is a drug marketed by Watson Labs, West-ward Pharms Int, and Hospira, and is included in three NDAs. It is available from two suppliers. Additional details are available on the SUFENTANIL CITRATE profile page.

The generic ingredient in SUFENTANIL CITRATE is sufentanil citrate. There are eight 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 NDA: 074534

Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 074534

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 074534

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sufentanil citrate
INJECTABLE;INJECTION 074534 ANDA Hospira, Inc. 0409-3382 0409-3382-49 10 VIAL, SINGLE-USE in 1 CARTON (0409-3382-49) > 1 mL in 1 VIAL, SINGLE-USE
sufentanil citrate
INJECTABLE;INJECTION 074534 ANDA Hospira, Inc. 0409-3382 0409-3382-50 10 VIAL, SINGLE-USE in 1 CARTON (0409-3382-50) > 2 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.05MG BASE/ML
Approval Date:Dec 11, 1996TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Farmers Insurance
Harvard Business School
Queensland Health
Argus Health

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