Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019785
Company: LANTHEUS MEDCL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIOLITE TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE;INJECTION Prescription AP Yes Yes
MIRALUMA TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/21/1990 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/30/2008 SUPPL-18 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019785s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/019785se5-018_SumR.pdf
06/08/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/14/2000 SUPPL-13 Labeling

Label is not available on this site.

01/22/2002 SUPPL-12 Labeling

Label is not available on this site.

06/10/1998 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/24/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/26/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/23/1997 SUPPL-6 Efficacy-New Patient Population

Label is not available on this site.

12/14/1995 SUPPL-5 Efficacy-New Patient Population

Label is not available on this site.

12/14/1995 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

02/28/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1992 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

01/30/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2008 SUPPL-18 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019785s018lbl.pdf

CARDIOLITE

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIOLITE TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE;INJECTION Prescription Yes AP 019785 LANTHEUS MEDCL
TECHNETIUM TC 99M SESTAMIBI TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE;INJECTION Prescription No AP 078809 CARDINAL HEALTH 414
TECHNETIUM TC 99M SESTAMIBI TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE;INJECTION Prescription No AP 078806 JUBILANT DRAXIMAGE
TECHNETIUM TC 99M SESTAMIBI TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE;INJECTION Prescription No AP 078098 MALLINKRODT NUCLEAR

MIRALUMA

There are no Therapeutic Equivalents.

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