Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018107
Company: CARDINAL HEALTH 414
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MDP-BRACCO 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
02/17/1981 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
11/13/2020 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018107Orig1s015ltr.pdf
09/10/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/21/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/26/2008 SUPPL-11 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018107s011ltr.pdf
11/23/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/21/1994 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1992 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/24/1993 SUPPL-6 Labeling

Label is not available on this site.

09/30/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/04/1997 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/24/1993 SUPPL-3 Labeling

Label is not available on this site.

04/12/1982 SUPPL-2 Labeling

Label is not available on this site.

04/13/1981 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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