Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018905
Company: GUERBET
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
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.

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

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