Details for New Drug Application (NDA): 021642

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NDA 021642 describes NASCOBAL, which is a drug marketed by Endo Operations and is included in two NDAs. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NASCOBAL profile page.

The generic ingredient in NASCOBAL is cyanocobalamin. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyanocobalamin profile page.

Summary for 021642

Tradename:	NASCOBAL
Applicant:	Endo Operations
Ingredient:	cyanocobalamin
Patents:	6

Pharmacology for NDA: 021642

Suppliers and Packaging for NDA: 021642

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642	NDA	ENDO USA, Inc.	49884-270	49884-270-82	4 SPRAY in 1 CARTON (49884-270-82)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.5MG/SPRAY
Approval Date:	Jan 31, 2005	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 1, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	NASAL ADMINISTRATION OF CYANOCOBALAMIN
Patent:	⤷ Sign Up	Patent Expiration:	Mar 12, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Aug 1, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION

Expired US Patents for NDA 021642

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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