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FDA NDA · NDA020928

GLUCAGON

Sponsor: LILLY

APPLICATION
NDA020928
TYPE
NDA
ORIGINAL APPROVAL
1998-09-11
LATEST ACTION
2021-01-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

GLUCAGON · ReferenceDiscontinued
GLUCAGON 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2021-01-26Labeling · Supplement 60 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 57 · standard — Letter ↗AP
2018-07-06Labeling · Supplement 56 · 901 required — Letter ↗AP
2018-04-18Labeling · Supplement 55 · standard — Label ↗AP
2015-12-18Manufacturing (CMC) · Supplement 51 · priorityAP
2015-07-21Manufacturing (CMC) · Supplement 50 · priorityAP
2014-08-11Manufacturing (CMC) · Supplement 49 · priorityAP
2014-03-27Manufacturing (CMC) · Supplement 48 · priorityAP
2013-09-27Manufacturing (CMC) · Supplement 47 · priorityAP
2004-02-24Labeling · Supplement 10 · standard — Letter ↗AP
2002-11-15Manufacturing (CMC) · Supplement 5 · priorityAP
2002-11-12Manufacturing (CMC) · Supplement 4 · priorityAP
2002-01-16Manufacturing (CMC) · Supplement 3 · priorityAP
2001-09-13Manufacturing (CMC) · Supplement 2 · priorityAP
1999-07-19Labeling · Supplement 1 · standardAP
1998-09-11Type 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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