Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018035
Company: JUBILANT DRAXIMAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DRAXIMAGE MDP-10 TECHNETIUM TC-99M MEDRONATE N/A INJECTABLE;INJECTION Discontinued None No No
DRAXIMAGE MDP-25 TECHNETIUM TC-99M MEDRONATE N/A INJECTABLE;INJECTION Prescription None 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
11/28/1978 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-035_Technescan%20MDP.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2011 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018035s032ltr.pdf
10/22/2010 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018035s029ltr.pdf
07/08/2009 SUPPL-24 Manufacturing (CMC)-Formulation Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018035s024ltr.pdf
02/27/2004 SUPPL-18 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18035scr018ltr.pdf
07/03/2002 SUPPL-17 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18035scm017ltr.pdf
04/02/1999 SUPPL-16 Labeling

Label is not available on this site.

04/02/1999 SUPPL-15 Labeling

Label is not available on this site.

08/23/1996 SUPPL-14 Labeling

Label is not available on this site.

12/30/1994 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/1988 SUPPL-12 Labeling

Label is not available on this site.

12/08/1988 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1979 SUPPL-4 Labeling

Label is not available on this site.

04/26/1979 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/29/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/30/1980 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/23/2011 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018035s032lbl.pdf
10/22/2010 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018035s029lbl.pdf
07/08/2009 SUPPL-24 Manufacturing (CMC)-Formulation Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018035s024lbl.pdf

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