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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019414
Company: BRACCO

Other Important Information from FDA

Products on NDA 019414

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019414

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
10/15/2020	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019414Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019414Orig1s021ltr.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.

Labels for NDA 019414

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2020	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019414Orig1s021lbl.pdf
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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