Details for New Drug Application (NDA): 019785

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NDA 019785 describes MIRALUMA, 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 MIRALUMA profile page.

The generic ingredient in MIRALUMA is technetium tc-99m sestamibi kit. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the technetium tc-99m sestamibi kit profile page.

Summary for 019785

Tradename:	MIRALUMA
Applicant:	Lantheus Medcl
Ingredient:	technetium tc-99m sestamibi kit
Patents:	0

Suppliers and Packaging for NDA: 019785

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001	11994-001-20	20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL
CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785	NDA	Lantheus Medical Imaging, Inc.	11994-001	11994-001-55	5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	N/A
Approval Date:	Dec 21, 1990	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	N/A
Approval Date:	May 23, 1997	TE:		RLD:	No

Expired US Patents for NDA 019785

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	⤷ Subscribe	⤷ Subscribe
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990	⤷ Subscribe	⤷ Subscribe
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	⤷ Subscribe	⤷ Subscribe
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	⤷ Subscribe	⤷ Subscribe
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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