Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078098
Company: MALLINKRODT NUCLEAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNETIUM TC 99M SESTAMIBI TECHNETIUM TC-99M SESTAMIBI KIT N/A INJECTABLE;INJECTION Prescription AP 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
09/22/2008 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078098s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/078098Orig1Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

TECHNETIUM TC 99M SESTAMIBI

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

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