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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020327
Company: BRACCO

Products on NDA 020327

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOVUE-200	IOPAMIDOL	41%	INJECTABLE;INJECTION	Discontinued	None	No	No
ISOVUE-250	IOPAMIDOL	51%	INJECTABLE;INJECTION	Discontinued	None	Yes	No
ISOVUE-300	IOPAMIDOL	61%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
ISOVUE-370	IOPAMIDOL	76%	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020327

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/1994	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
04/25/2023	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020327s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018735Orig1s070;020327Orig1s025ltr.pdf
02/18/2022	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020327s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018735Orig1s067; 020327Orig1s023ltr.pdf
02/16/2018	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020327s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020327Orig1s014ltr.pdf
04/05/2017	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020327s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018735Orig1s057,020327Orig1s012ltr.pdf
01/22/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020327s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020327Orig1s011ltr.pdf
07/06/2015	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018735Orig1s056,020327Orig1s010ltr.pdf
06/20/2014	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020327s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020327Orig1s008ltr.pdf
08/01/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020327Orig1s007ltr.pdf
07/26/2005	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/05/2003	SUPPL-4	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20327scs004ltr.pdf
12/09/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/20/2002	SUPPL-2	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20327slr002ltr.pdf
12/17/1996	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 020327

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/25/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020327s025lbl.pdf
02/18/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020327s023lbl.pdf
02/16/2018	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020327s014lbl.pdf
04/05/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020327s012lbl.pdf
01/22/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020327s011lbl.pdf
07/06/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018735s056,020327s010lbl.pdf
06/20/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020327s008lbl.pdf
08/01/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020327s007lbl.pdf

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