An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018905
Company: GUERBET

Products on NDA 018905

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEXABRIX	IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM	39.3%;19.6%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018905

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/1985	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	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
04/05/2017	SUPPL-25	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018905s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018905Orig1s025ltr.pdf
07/06/2015	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018905s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018905Orig1s024ltr.pdf
02/23/2001	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/27/1999	SUPPL-21	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/26/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/13/1995	SUPPL-19	Labeling		Label is not available on this site.
08/28/1992	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/17/1994	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/1992	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
03/30/1994	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/30/1990	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
07/03/1989	SUPPL-12	Labeling		Label is not available on this site.
01/31/1989	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/10/1989	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/30/1986	SUPPL-6	Labeling		Label is not available on this site.
11/21/1986	SUPPL-4	Labeling		Label is not available on this site.
10/22/1986	SUPPL-2	Efficacy-New Indication		Label is not available on this site.
06/03/1988	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 018905

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2017	SUPPL-25	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018905s025lbl.pdf
07/06/2015	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018905s024lbl.pdf

Top