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FDA NDA · NDA020918

GLUCAGEN

Sponsor: NOVO NORDISK

APPLICATION
NDA020918
TYPE
NDA
ORIGINAL APPROVAL
1998-06-22
LATEST ACTION
2021-07-20
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

GLUCAGEN · ReferenceDiscontinued
GLUCAGON HYDROCHLORIDE EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAMUSCULAR, INTRAVENOUS
GLUCAGEN · ReferenceDiscontinued
GLUCAGON HYDROCHLORIDE EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Approval history

2021-07-20Labeling · Supplement 56 · standard — Letter ↗AP
2021-03-11Labeling · Supplement 54 · standard — Letter ↗AP
2020-09-03Labeling · Supplement 53 · standard — Letter ↗AP
2018-07-06Labeling · Supplement 52 · 901 required — Label ↗AP
2018-04-18Labeling · Supplement 49 · standard — Label ↗AP
2016-02-11Manufacturing (CMC) · Supplement 47 · priorityAP
2015-12-10Labeling · Supplement 43 · standard — Letter ↗AP
2015-10-08Manufacturing (CMC) · Supplement 44 · priorityAP
2014-03-14Labeling · Supplement 42 · standard — Letter ↗AP
2013-04-26Manufacturing (CMC) · Supplement 39 · priorityAP
2013-04-26Labeling · Supplement 40 · standard — Letter ↗AP
2013-01-16Manufacturing (CMC) · Supplement 38 · priorityAP
2011-12-29Labeling · Supplement 34 · standard — Label ↗AP
2010-12-15Labeling · Supplement 30 · unknown — Label ↗AP
2007-06-28Manufacturing (CMC) · Supplement 23AP
2005-11-14Labeling · Supplement 17 · standard — Letter ↗AP
2004-12-23Manufacturing (CMC) · Supplement 12 · priority — Label ↗AP
2004-03-01Labeling · Supplement 8 · standard — Label ↗AP
2002-08-05Manufacturing (CMC) · Supplement 5 · priorityAP
2002-07-11Labeling · Supplement 3 · standard — Review ↗AP
2002-04-01Manufacturing (CMC) · Supplement 4 · priorityAP
2000-08-18Labeling · Supplement 2 · standardAP
2000-05-30Labeling · Supplement 1 · standardAP
1998-06-22Type 3 - New Dosage Form · Original · priority — Review ↗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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