Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019882
Company: CURIUM

Products on NDA 019882

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNESCAN MAG3	TECHNETIUM TC-99M MERTIATIDE KIT	N/A	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019882

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1990	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2014	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/16/2001	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/08/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/11/1994	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
03/11/1994	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/27/1992	SUPPL-3	Labeling		Label is not available on this site.
02/26/1993	SUPPL-2	Labeling		Label is not available on this site.
11/27/1992	SUPPL-1	Efficacy-New Patient Population		Label is not available on this site.

Therapeutic Equivalents for NDA 019882

TECHNESCAN MAG3

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