Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020123
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNISCAN GADODIAMIDE 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
01/08/1993 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
11/07/2018 SUPPL-47 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-46 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020123Orig1s046,022066Orig1s008Ltr.pdf
06/06/2016 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/14/2014 SUPPL-43 Labeling-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
06/23/2014 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/03/2014 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/14/2014 SUPPL-40 Labeling-Container/Carton Labels

Label is not available on this site.

08/27/2013 SUPPL-39 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, 022066Orig1s004ltr.pdf
12/20/2010 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020123s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020123s037,022066s002ltr.pdf
12/14/2007 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020123s035ltr.pdf
09/05/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020123s034_ltr.pdf
08/12/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/2002 SUPPL-23 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123scm023ltr.pdf
06/28/2002 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s022ltr.pdf
05/20/2002 SUPPL-21 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s021ltr.pdf
03/15/2002 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/30/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/2002 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20123s018ltr.pdf
03/13/2001 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/17/2001 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/03/1997 SUPPL-15 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020123_s015.pdf
03/19/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/27/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/17/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1996 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.

02/05/1996 SUPPL-5 Efficacy-New Indication

Label is not available on this site.

02/05/1996 SUPPL-4 Efficacy-New Dosing Regimen

Label is not available on this site.

06/06/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/04/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/26/1993 SUPPL-1 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
11/07/2018 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s047,022066s009lbl.pdf
04/26/2018 SUPPL-46 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020123s046lbl.pdf
11/14/2014 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022066s007,020123s043lbl.pdf
08/27/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022066s00420123s039lbl.pdf
12/20/2010 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020123s037lbl.pdf
12/14/2007 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s035lbl.pdf
09/05/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020123s034lbl.pdf

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