Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018511
Company: JUBILANT DRAXIMAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DRAXIMAGE DTPA TECHNETIUM TC-99M PENTETATE KIT 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
12/29/1989 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
12/26/2017 SUPPL-28 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018511s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018511Orig1s028ltr.pdf
01/05/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/27/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/28/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/22/2017 SUPPL-20 Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf
09/23/2011 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018511s019ltr.pdf
12/10/2001 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/02/1999 SUPPL-6 Labeling

Label is not available on this site.

04/02/1999 SUPPL-5 Labeling

Label is not available on this site.

08/23/1996 SUPPL-4 Labeling

Label is not available on this site.

08/09/1994 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/07/1990 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
12/26/2017 SUPPL-28 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018511s028lbl.pdf
12/22/2017 SUPPL-20 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf
09/23/2011 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018511s019lbl.pdf

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