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FDA Approval

Zegalogue

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Zealand Pharma US, Inc
DUNS: 117052161
Effective Date
October 4, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Dasiglucagon(0.6 mg in 0.6 mL)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zegalogue

Product Details

NDC Product Code
80644-0013
Application Number
NDA214231
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
October 4, 2023
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 3.82 mg in 0.6 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.44 mg in 0.6 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: AD4J2O47FQClass: ACTIBQuantity: 0.6 mg in 0.6 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Zegalogue

Product Details

NDC Product Code
80644-0012
Application Number
NDA214231
Marketing Category
NDA (C73594)
Route of Administration
SUBCUTANEOUS
Effective Date
October 4, 2023
Code: AD4J2O47FQClass: ACTIBQuantity: 0.6 mg in 0.6 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6.44 mg in 0.6 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TROMETHAMINEInactive
Code: 023C2WHX2VClass: IACTQuantity: 3.82 mg in 0.6 mL
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