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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018956
Company: GE HEALTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNIPAQUE 12 IOHEXOL 2.6% SOLUTION;ORAL Prescription None Yes Yes
OMNIPAQUE 140 IOHEXOL 30.2% INJECTABLE;INJECTION Prescription None Yes Yes
OMNIPAQUE 180 IOHEXOL 38.8% SOLUTION;INJECTION, ORAL, RECTAL Prescription None Yes Yes
OMNIPAQUE 210 IOHEXOL 45.3% INJECTABLE;INJECTION Discontinued None No No
OMNIPAQUE 240 IOHEXOL 51.8% SOLUTION;INJECTION, ORAL, RECTAL Prescription None Yes Yes
OMNIPAQUE 300 IOHEXOL 64.7% SOLUTION;INJECTION, ORAL, RECTAL Prescription None Yes Yes
OMNIPAQUE 350 IOHEXOL 75.5% SOLUTION;INJECTION, ORAL Prescription None Yes Yes
OMNIPAQUE 70 IOHEXOL 15.1% SOLUTION;URETHRAL Discontinued None No No
OMNIPAQUE 9 IOHEXOL 1.9% SOLUTION;ORAL Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/18/2022 SUPPL-113 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018956s113,020608s045lbl.pdf
08/05/2021 SUPPL-112 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018956s112lbl.pdf
11/04/2020 SUPPL-108 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956Orig1s108lbl.pdf
07/02/2020 SUPPL-105 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956s105lbl.pdf
07/02/2020 SUPPL-105 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018956s105lbl.pdf
04/17/2018 SUPPL-101 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf
04/17/2018 SUPPL-101 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018956s101lbl.pdf
04/05/2017 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018956s099lbl.pdf
07/06/2015 SUPPL-95 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018956s095,020608s031lbl.pdf
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