Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020123
Company: GE HEALTHCARE
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 |
|---|---|---|---|---|---|
| 01/26/2024 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020123s050,022066s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020123Orig1s050; 022066Orig1s013ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 01/26/2024 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020123s050,022066s013lbl.pdf | |
| 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 |