Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078098
Company: CURIUM

Products on ANDA 078098

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 078098

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
05/17/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/09/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078098

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