Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022066
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNISCAN GADODIAMIDE 14.35GM/50ML (287MG/ML) INJECTABLE;INJECTION Discontinued None No No
OMNISCAN GADODIAMIDE 28.7GM/100ML (287MG/ML) INJECTABLE;INJECTION 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
09/05/2007 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022066s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022066s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/2019 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022066s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022066Orig1s010ltr.pdf
11/07/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s047,022066s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020123Orig1s047,022066Orig1s009ltredt.pdf
04/26/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020123Orig1s046,022066Orig1s008Ltr.pdf
11/14/2014 SUPPL-7 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020123Orig1s043,022066Orig1s007ltr.pdf
12/11/2012 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020427Orig1s005,022006Orig1s006ltr.pdf
05/14/2014 SUPPL-5 Labeling-Container/Carton Labels

Label is not available on this site.

08/27/2013 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020123Orig1s039,%20022066Orig1s004ltr.pdf
12/20/2010 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022066s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020123s037,022066s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/23/2019 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022066s010lbl.pdf
11/07/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s047,022066s009lbl.pdf
04/26/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022066s008lbl.pdf
11/14/2014 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf
08/27/2013 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf
12/20/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022066s002lbl.pdf
09/05/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022066lbl.pdf

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