Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020316
Company: GUERBET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXILAN-300 IOXILAN 62% INJECTABLE;INJECTION Discontinued None No No
OXILAN-350 IOXILAN 73% 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
12/21/1995 ORIG-1 Approval Type 1 - New Molecular Entity 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-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020316s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020316Orig1s029ltr.pdf
07/06/2015 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020316Orig1s028ltr.pdf
11/12/2006 SUPPL-21 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020316s021LTR.pdf
01/06/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20316slr016ltr.pdf
08/12/2002 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/17/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/30/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/04/1999 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/22/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/15/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/17/1997 SUPPL-5 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-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020316s029lbl.pdf
07/06/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020316Orig1s028lbl.pdf

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