Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078806
Company: JUBILANT DRAXIMAGE
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
04/29/2009 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/01/2018 SUPPL-15 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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