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Last Updated: March 28, 2024

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
Formulation / Manufacturing:see details
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:RXDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:Dec 21, 1990TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthN/A
Approval Date:May 23, 1997TE:RLD:No

Expired US Patents for NDA 019785

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

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