Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019414
Company: BRACCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARDIOGEN-82 RUBIDIUM CHLORIDE RB-82 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
12/29/1989 ORIG-1 Approval Type 1 - New Molecular Entity 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
10/24/2019 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019414Orig1s024ltr.pdf
04/26/2019 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019414Orig1s022ltr.pdf
12/05/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/22/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/08/2012 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019414s014ltr.pdf
07/29/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019414s012ltr.pdf
07/21/2009 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019414s011ltr.pdf
04/05/2001 SUPPL-6 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19414S6ltr.pdf
03/23/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/29/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/21/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/14/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/06/1990 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
10/24/2019 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s024lbl.pdf
04/26/2019 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019414s022lbl.pdf
02/08/2012 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf
07/29/2010 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf
07/21/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf

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