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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 212097


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NDA 212097 describes GVOKE PFS, which is a drug marketed by Xeris and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the GVOKE PFS profile page.

The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the glucagon profile page.
Summary for 212097
Tradename:GVOKE PFS
Applicant:Xeris
Ingredient:glucagon
Patents:2
Medical Subject Heading (MeSH) Categories for 212097
Suppliers and Packaging for NDA: 212097
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GVOKE HYPOPEN glucagon SOLUTION;SUBCUTANEOUS 212097 NDA Xeris Pharmaceuticals, Inc. 72065-120 72065-120-11 1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC
GVOKE KIT glucagon SOLUTION;SUBCUTANEOUS 212097 NDA Xeris Pharmaceuticals, Inc. 72065-120 72065-120-11 1 POUCH in 1 CARTON (72065-120-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .1 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;SUBCUTANEOUSStrength0.5MG/0.1ML (0.5MG/0.1ML)
Approval Date:Sep 10, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 22, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEVERE HYPOGLYCEMIA
Patent:⤷  Sign UpPatent Expiration:Apr 22, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEVERE HYPOGLYCEMIA

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength1MG/0.2ML (1MG/0.2ML)
Approval Date:Sep 10, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 22, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEVERE HYPOGLYCEMIA

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