Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017944
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MPI DMSA KIDNEY REAGENT TECHNETIUM TC-99M SUCCIMER KIT N/A INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/18/1982 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
02/28/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/22/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/24/2003 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17944slr018ltr.pdf
11/25/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/29/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/12/1999 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/17/1994 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/17/1989 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/12/1985 SUPPL-5 Labeling

Label is not available on this site.

01/30/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1986 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/27/1983 SUPPL-2 Labeling

Label is not available on this site.

04/10/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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