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FDA NDA · NDA201849

GLUCAGON

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA201849
TYPE
NDA
ORIGINAL APPROVAL
2015-05-08
LATEST ACTION
2025-07-30
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

GLUCAGON · ReferencePrescription
GLUCAGON HYDROCHLORIDE EQ 1MG BASE/VIAL · POWDER · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
GLUCAGON · ReferencePrescription
GLUCAGON HYDROCHLORIDE EQ 1MG BASE/VIAL · POWDER · INTRAMUSCULAR, INTRAVENOUS

Approval history

2025-07-30Labeling · Supplement 24 · standard — Label ↗AP
2022-07-14Labeling · Supplement 13 · standard — Letter ↗AP
2021-07-29Labeling · Supplement 9 · standard — Letter ↗AP
2019-09-09Efficacy · Supplement 5 · standard — Letter ↗AP
2015-12-01Labeling · Supplement 2 · standard — Letter ↗AP
2015-11-03Manufacturing (CMC) · Supplement 3 · standardAP
2015-11-03Manufacturing (CMC) · Supplement 1 · standardAP
2015-05-08Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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