← FDA DRUG APPROVALS

FDA NDA · NDA214231

ZEGALOGUE

dasiglucagon

Sponsor: ZEALAND PHARMA

APPLICATION
NDA214231
TYPE
NDA
ORIGINAL APPROVAL
2021-03-22
LATEST ACTION
2026-06-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ZEGALOGUE · ReferenceDiscontinued
DASIGLUCAGON HYDROCHLORIDE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) · SOLUTION · SUBCUTANEOUS
ZEGALOGUE (AUTOINJECTOR) · ReferenceDiscontinued
DASIGLUCAGON HYDROCHLORIDE EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-06-18Efficacy · Supplement 4 · priority — Letter ↗AP
2021-03-22Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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