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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009190
Company: GUERBET

Products on NDA 009190

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIPIODOL	ETHIODIZED OIL	EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)	OIL;INTRALYMPHATIC, INTRAUTERINE	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 009190

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/1954	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2023	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009190s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/009190Orig1s032ltr.pdf
06/10/2020	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009190Orig1s029, s031ltr.pdf
06/10/2020	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/009190Orig1s029, s031ltr.pdf
09/28/2018	SUPPL-27	Labeling-Container/Carton Labels		Label is not available on this site.
04/04/2014	SUPPL-24	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s024ltr.pdf
01/23/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
03/21/2014	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009190Orig1s021ltr.pdf
09/10/1985	SUPPL-16	Labeling		Label is not available on this site.
11/14/1979	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
11/14/1979	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/07/1978	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 009190

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2023	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/009190s032lbl.pdf
06/10/2020	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf
06/10/2020	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/009190s029s031lbl.pdf
04/04/2014	SUPPL-24	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s024lbl.pdf
03/21/2014	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009190s021lbl.pdf

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