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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212097
Company: XERIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GVOKE HYPOPEN GLUCAGON 0.5MG/0.1ML (0.5MG/0.1ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
GVOKE HYPOPEN GLUCAGON 1MG/0.2ML (1MG/0.2ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
GVOKE KIT GLUCAGON 0.5MG/0.1ML (0.5MG/0.1ML) SOLUTION;SUBCUTANEOUS Prescription None No No
GVOKE KIT GLUCAGON 1MG/0.2ML (1MG/0.2ML) SOLUTION;SUBCUTANEOUS Prescription None No No
GVOKE PFS GLUCAGON 0.5MG/0.1ML (0.5MG/0.1ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
GVOKE PFS GLUCAGON 1MG/0.2ML (1MG/0.2ML) SOLUTION;SUBCUTANEOUS 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
09/10/2019 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212097Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212097Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212097Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2021 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212097s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212097Orig1s008ltr.pdf
08/20/2021 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212097Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212097Orig1s007ltr.pdf
04/07/2020 SUPPL-1 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212097Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/20/2021 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212097Orig1s007lbl.pdf
07/15/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212097s008lbl.pdf
09/10/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212097Orig1s000lbl.pdf
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