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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021489
Company: BRACCO

Medication Guide

Other Important Information from FDA

Products on NDA 021489

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROHANCE MULTIPACK	GADOTERIDOL	279.3MG/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021489

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/09/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21489_proHance_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21489ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021489s000_ProhanceTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2025	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021489s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020131Orig1s044;021489Orig1s025ltr.pdf
07/23/2024	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s043,021489s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s043;021489Orig1s024ltr.pdf
08/14/2024	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s042,021489s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s042, 021489Orig1s023ltr.pdf
01/26/2024	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s040,021489s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020131Orig1s040; 021489Orig1s021ltr.pdf
11/19/2022	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021489Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021489Orig1s018ltr.pdf
05/06/2021	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021489s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021489Orig1s016ltr.pdf
12/19/2020	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021489Orig1s014ltr.pdf
11/02/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021489Orig1s010,021357Orig1s018,021358Orig1s017ltr.pdf
04/26/2018	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020131Orig1s028,021489Orig1s006Ltr.pdf
09/15/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021489s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021489Orig1s005ltr.pdf
07/22/2014	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021489s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021489Orig1s004ltr.pdf
08/13/2013	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020131Orig1s026,021489Orig1s003ltr.pdf
12/20/2010	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021489s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020131s024,021489s002ltr.pdf
09/04/2007	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020131s023, 021489s001ltr.pdf

Labels for NDA 021489

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2025	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021489s025lbl.pdf
08/14/2024	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s042,021489s023lbl.pdf
07/23/2024	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s043,021489s024lbl.pdf
01/26/2024	SUPPL-21	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s040,021489s021lbl.pdf
01/26/2024	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020131s040,021489s021lbl.pdf
11/19/2022	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021489Orig1s018lbl.pdf
05/06/2021	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021489s016lbl.pdf
12/19/2020	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021489s014lbl.pdf
11/02/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s010lbl.pdf
04/26/2018	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf
04/26/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021489s006lbl.pdf
09/15/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021489s005lbl.pdf
07/22/2014	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021489s004lbl.pdf
08/13/2013	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf
12/20/2010	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021489s002lbl.pdf
09/04/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf
10/09/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21489_proHance_lbl.pdf

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