FDA.reportPublic FDA data

Application 020918

Type
NDA
Sponsor
NOVO NORDISK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLUCAGENGLUCAGON HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/VIALYesYes
002GLUCAGENGLUCAGON HYDROCHLORIDEPOWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUSEQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0169-7065GlucaGen HypoKitglucagon hydrochlorideNovo NordiskNDACurrent
0169-7065GlucaGen HypoKitglucagon hydrochlorideNovo NordiskNDACurrent
0169-7065GlucaGen HypoKitglucagon hydrochlorideNovo NordiskNDACurrent
0169-7065GlucaGen HypoKitglucagon hydrochlorideNovo NordiskNDACurrent
0169-7065GlucaGen HypoKitglucagon hydrochlorideNovo NordiskNDACurrent
0597-0053GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0053GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0053GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0053GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0053GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0260GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0260GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0260GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0260GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0260GlucaGenglucagon hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68169SUPPL2021-07-23
68144SUPPL2021-07-22
66764SUPPL2021-03-12
66761SUPPL2021-03-12
64589SUPPL2020-09-17
54866SUPPL2018-07-09
53763SUPPL2018-04-20
53737SUPPL2018-04-19
13735SUPPL2015-12-15
3746SUPPL2015-12-15
3745SUPPL2014-03-19
3744SUPPL2013-04-30
26190SUPPL2012-01-17
13734SUPPL2012-01-06
35640SUPPL2010-12-22
3743SUPPL2010-12-21
41811SUPPL2007-07-20
41810SUPPL2007-07-20
35639SUPPL2005-11-18
26189SUPPL2005-11-18
41809ORIG2005-06-23
13733SUPPL2004-12-29
3742SUPPL2004-12-29
35638SUPPL2004-04-05
26188SUPPL2004-03-02
3741SUPPL2002-07-11
26187ORIG1998-06-22
13732ORIG1998-06-22