Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078809
Company: CARDINAL HEALTH 414

Products on ANDA 078809

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078809

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2009	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
01/10/2016	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078809

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	078098	CURIUM
TECHNETIUM TC 99M SESTAMIBI	TECHNETIUM TC-99M SESTAMIBI KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	078806	JUBILANT DRAXIMAGE