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Generated: May 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022569

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NDA 022569 describes LAZANDA, which is a drug marketed by Elefsee Pharms Intl and is included in one NDA. It is available from three suppliers. There are five patents protecting this drug. Additional details are available on the LAZANDA profile page.

The generic ingredient in LAZANDA is fentanyl citrate. There are thirty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 022569
Tradename:LAZANDA
Applicant:Elefsee Pharms Intl
Ingredient:fentanyl citrate
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 022569
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 022569
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569 NDA Depomed, Inc. 13913-009 13913-009-01 1 BOTTLE, SPRAY in 1 CARTON (13913-009-01) > 8 SPRAY in 1 BOTTLE, SPRAY
LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569 NDA Depomed, Inc. 13913-010 13913-010-01 1 BOTTLE, SPRAY in 1 CARTON (13913-010-01) > 8 SPRAY in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.1MG BASE
Approval Date:Jun 30, 2011TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Oct 3, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:➤ Try a Free TrialPatent Expiration:Jan 16, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:➤ Try a Free TrialPatent Expiration:Jan 8, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022569

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Elefsee Pharms Intl LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-001 Jun 30, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Elefsee Pharms Intl LAZANDA fentanyl citrate SPRAY, METERED;NASAL 022569-002 Jun 30, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Chinese Patent Office
Express Scripts
Julphar
Queensland Health
Covington

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