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Details for New Drug Application (NDA): 022569

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NDA 022569 describes LAZANDA, which is a drug marketed by Depomed Inc and is included in one NDA. It is available from two suppliers. There are four 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. Eighteen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for NDA: 022569

Tradename:
LAZANDA
Applicant:
Depomed Inc
Ingredient:
fentanyl citrate
Patents:4
Therapeutic Class:Analgesics
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrengthEQ 0.1MG BASE
Approval Date:Jun 30, 2011TE:RLD:No
Patent:9,078,814Patent Expiration:Jan 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:6,432,440Patent Expiration:Apr 20, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT CANCER PAIN
Patent:8,216,604Patent Expiration:Oct 3, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER


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