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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 020256

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NDA 020256 describes NEUROLITE, which is a drug marketed by Lantheus Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the NEUROLITE profile page.

The generic ingredient in NEUROLITE is technetium tc-99m bicisate kit. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m bicisate kit profile page.

Summary for 020256

Tradename:	NEUROLITE
Applicant:	Lantheus Medcl
Ingredient:	technetium tc-99m bicisate kit
Patents:	0
Formulation / Manufacturing:	see details

Suppliers and Packaging for NDA: 020256

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256	NDA	Lantheus Medical Imaging, Inc.	11994-006	11994-006-02	2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01)
NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256	NDA	Lantheus Medical Imaging, Inc.	11994-006	11994-006-05	5 KIT in 1 PACKAGE, COMBINATION (11994-006-05) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	N/A
Approval Date:	Nov 23, 1994	TE:		RLD:	Yes

Expired US Patents for NDA 020256

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256-001	Nov 23, 1994	⤷ Try a Trial	⤷ Try a Trial
Lantheus Medcl	NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256-001	Nov 23, 1994	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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