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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212097
Company: XERIS

Products on NDA 212097

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	1MG/0.2ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
GVOKE PFS	GLUCAGON	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No
GVOKE PFS	GLUCAGON	1MG/0.2ML (1MG/0.2ML)	SOLUTION;SUBCUTANEOUS	Prescription	None	Yes	Yes
GVOKE VIALDX	GLUCAGON	1MG/0.2ML (1MG/0.2ML)	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212097

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2023	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212097Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212097Orig1s013ltr.pdf
03/14/2025	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212097s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212097Orig1s012ltr.pdf
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

Labels for NDA 212097

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2025	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212097s012lbl.pdf
12/22/2023	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212097Orig1s013lbl.pdf
12/22/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212097Orig1s013lbl.pdf
12/22/2023	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212097Orig1s013lbl.pdf
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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