Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018124
Company: PHARMALUCENCE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIS-MDP TECHNETIUM TC-99M MEDRONATE KIT N/A INJECTABLE;INJECTION Prescription 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
08/29/1979 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
05/17/2016 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/26/2015 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/21/2014 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/19/2005 SUPPL-13 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018124s013ltr.pdf
05/27/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1989 SUPPL-11 Labeling

Label is not available on this site.

04/02/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/27/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/02/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/29/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/27/1984 SUPPL-3 Labeling

Label is not available on this site.

03/27/1984 SUPPL-2 Labeling

Label is not available on this site.

08/18/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/19/2005 SUPPL-13 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018124s013lbl.pdf

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