Details for New Drug Application (NDA): 022569

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NDA 022569 describes LAZANDA, which is a drug marketed by Btcp Pharma and is included in one NDA. 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. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for 022569

Tradename:	LAZANDA
Applicant:	Btcp Pharma
Ingredient:	fentanyl citrate
Patents:	5

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 30, 2011	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Oct 3, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:	⤷ Sign Up	Patent Expiration:	Jan 16, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
Patent:	⤷ Sign Up	Patent Expiration:	Jan 8, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022569

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-002	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-003	Dec 21, 2015	⤷ Sign Up	⤷ Sign Up
Btcp Pharma	LAZANDA	fentanyl citrate	SPRAY, METERED;NASAL	022569-001	Jun 30, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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