Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208994
Company: SUN PHARM INDS INC

Products on ANDA 208994

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNETIUM TC99M MERTIATIDE KIT	TECHNETIUM TC-99M MERTIATIDE KIT	N/A	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208994

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208994Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 208994

TECHNETIUM TC99M MERTIATIDE KIT

INJECTABLE;INJECTION; N/A
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TECHNESCAN MAG3	TECHNETIUM TC-99M MERTIATIDE KIT	N/A	INJECTABLE;INJECTION	Prescription	Yes	AP	019882	CURIUM
TECHNETIUM TC99M MERTIATIDE KIT	TECHNETIUM TC-99M MERTIATIDE KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	206489	MEDI-RADIOPHARMA
TECHNETIUM TC99M MERTIATIDE KIT	TECHNETIUM TC-99M MERTIATIDE KIT	N/A	INJECTABLE;INJECTION	Prescription	No	AP	208994	SUN PHARM INDS INC