Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018141
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECHNETIUM TC 99M MPI MDP TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE;INJECTION Discontinued None No No
TECHNETIUM TC 99M MPI MDP TECHNETIUM TC-99M MEDRONATE 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
06/26/1979 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
09/05/2007 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018141s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018141s029_ltr.pdf
11/25/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/29/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/12/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1992 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/31/1988 SUPPL-20 Labeling

Label is not available on this site.

02/17/1989 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1989 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/12/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/30/1985 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/09/1985 SUPPL-9 Labeling

Label is not available on this site.

05/09/1985 SUPPL-8 Labeling

Label is not available on this site.

05/09/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/06/1980 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/09/1981 SUPPL-5 Labeling

Label is not available on this site.

03/31/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/09/1980 SUPPL-3 Labeling

Label is not available on this site.

06/12/1989 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/05/2007 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018141s029lbl.pdf

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