Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009190
Company: GUERBET
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
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
04/04/2014 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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