Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212097

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GVOKE HYPOPEN (GLUCAGON)
0.5MG/0.1ML (0.5MG/0.1ML)
Marketing Status: Prescription
Active Ingredient: GLUCAGON
Proprietary Name: GVOKE HYPOPEN
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 0.5MG/0.1ML (0.5MG/0.1ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212097
Product Number: 003
Approval Date: Sep 10, 2019
Applicant Holder Full Name: XERIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GVOKE HYPOPEN (GLUCAGON)
1MG/0.2ML (1MG/0.2ML)
Marketing Status: Prescription
Active Ingredient: GLUCAGON
Proprietary Name: GVOKE HYPOPEN
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 1MG/0.2ML (1MG/0.2ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212097
Product Number: 004
Approval Date: Sep 10, 2019
Applicant Holder Full Name: XERIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GVOKE PFS (GLUCAGON)
0.5MG/0.1ML (0.5MG/0.1ML)
Marketing Status: Prescription
Active Ingredient: GLUCAGON
Proprietary Name: GVOKE PFS
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 0.5MG/0.1ML (0.5MG/0.1ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212097
Product Number: 001
Approval Date: Sep 10, 2019
Applicant Holder Full Name: XERIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
GVOKE PFS (GLUCAGON)
1MG/0.2ML (1MG/0.2ML)
Marketing Status: Prescription
Active Ingredient: GLUCAGON
Proprietary Name: GVOKE PFS
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 1MG/0.2ML (1MG/0.2ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212097
Product Number: 002
Approval Date: Sep 10, 2019
Applicant Holder Full Name: XERIS PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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