NDA 020918

NOVO NORDISK

FDA Drug Application

Application #020918

Documents

• Letter: 2002-07-11
• Letter: 2004-12-29
• Letter: 2010-12-21
• Letter: 2013-04-30
• Letter: 2014-03-19
• Letter: 2015-12-15
• Label: 1998-06-22
• Label: 2004-12-29
• Label: 2012-01-06
• Label: 2015-12-15
• Letter: 1998-06-22
• Letter: 2004-03-02
• Letter: 2005-11-18
• Letter: 2012-01-17
• Label: 2004-04-05
• Label: 2005-11-18
• Label: 2010-12-22
• Review: 2005-06-23
• Review: 2007-07-20
• Review: 2007-07-20
• Label: 2018-04-19
• Letter: 2018-04-20
• Label: 2018-07-09
• Letter: 2020-09-17
• Letter: 2021-03-12
• Label: 2021-03-12
• Letter: 2021-07-22
• Label: 2021-07-23

Application Sponsors

NDA 020918

NOVO NORDISK

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1MG BASE/VIAL

1

GLUCAGEN

GLUCAGON HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1998-06-22	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2000-08-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-07-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-08-05	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2004-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2004-12-23	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2005-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2007-06-28	N/A
LABELING; Labeling	SUPPL	30	AP	2010-12-15	UNKNOWN
LABELING; Labeling	SUPPL	34	AP	2011-12-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2013-01-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2013-04-26	PRIORITY
LABELING; Labeling	SUPPL	40	AP	2013-04-26	STANDARD
LABELING; Labeling	SUPPL	42	AP	2014-03-14	STANDARD
LABELING; Labeling	SUPPL	43	AP	2015-12-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2015-10-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2016-02-11	PRIORITY
LABELING; Labeling	SUPPL	49	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	52	AP	2018-07-06	901 REQUIRED
LABELING; Labeling	SUPPL	53	AP	2020-09-03	STANDARD
LABELING; Labeling	SUPPL	54	AP	2021-03-11	STANDARD
LABELING; Labeling	SUPPL	56	AP	2021-07-20	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	12	Null	0
SUPPL	30	Null	7
SUPPL	34	Null	15
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	15
SUPPL	42	Null	15
SUPPL	43	Null	6
SUPPL	44	Null	0
SUPPL	47	Null	0
SUPPL	49	Null	15
SUPPL	52	Null	7
SUPPL	53	Null	15
SUPPL	54	Null	15
SUPPL	56	Null	7

CDER Filings

NOVO NORDISK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20918
            [companyName] => NOVO NORDISK
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLUCAGEN","activeIngredients":"GLUCAGON HYDROCHLORIDE","strength":"EQ 1MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/06\/2018","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020918s052lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2018","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020918s049lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2018","submission":"SUPPL-49","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020918s049lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2018","submission":"SUPPL-49","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020918s049lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2015","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020918s043lbl.pdf\"}]","notes":""},{"actionDate":"12\/29\/2011","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020918s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2010","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020918s030lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2005","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020918s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2004","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20918s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2004","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20918slr008_glucagen_lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20918lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GLUCAGEN","submission":"GLUCAGON HYDROCHLORIDE","actionType":"EQ 1MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-07-06
        )

)