Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019882
Company: CURIUM
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
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.

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 208994 PHARMALUCENCE

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