BLA 020986

NOVO NORDISK INC

FDA Drug Application

Application #020986

Documents

• Letter: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Label: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Review: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Other: 2020-03-23
• Label: 2020-03-23
• Label: 2020-03-23
• Letter: 2020-03-23
• Letter: 2020-03-23
• Other: 2020-03-31
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Amendment 2: 1900-01-01
• Pediatric Amendment 3: 1900-01-01
• Pediatric Amendment 6: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 2020-03-23
• Letter: 2021-03-24
• Label: 2021-03-24
• Review: 2021-09-24
• Review: 2021-09-24
• Letter: 2022-11-02
• Label: 2022-11-07

Application Sponsors

BLA 020986

NOVO NORDISK INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	INJECTABLE;SUBCUTANEOUS	1000 UNITS/10ML (100 UNITS/ML)	0	NOVOLOG	INSULIN ASPART RECOMBINANT
002	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	0	NOVOLOG PENFILL	INSULIN ASPART RECOMBINANT
003	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	0	NOVOLOG FLEXPEN	INSULIN ASPART RECOMBINANT
004	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	0	NOVOLOG INNOLET	INSULIN ASPART RECOMBINANT
005	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	0	NOVOLOG FLEXTOUCH	INSULIN ASPART RECOMBINANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2000-06-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-04-11	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2001-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-03-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-07-29	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2002-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-11-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-12-04	STANDARD
LABELING; Labeling	SUPPL	19	AP	2004-10-08	STANDARD
LABELING; Labeling	SUPPL	20	AP	2004-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2004-04-23	STANDARD
LABELING; Labeling	SUPPL	24	AP	2004-07-30	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2005-10-21	UNKNOWN
EFFICACY; Efficacy	SUPPL	33	AP	2005-09-13	PRIORITY
EFFICACY; Efficacy	SUPPL	37	AP	2007-01-26	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2006-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2009-07-14	N/A
EFFICACY; Efficacy	SUPPL	47	AP	2008-03-14	STANDARD
LABELING; Labeling	SUPPL	49	AP	2008-09-03	STANDARD
LABELING; Labeling	SUPPL	50	AP	2008-09-03	STANDARD
LABELING; Labeling	SUPPL	53	AP	2008-11-28	STANDARD
LABELING; Labeling	SUPPL	54	AP	2009-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2009-07-17	N/A
LABELING; Labeling	SUPPL	57	AP	2012-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	2010-06-25	N/A
LABELING; Labeling	SUPPL	59	AP	2015-02-25	UNKNOWN
LABELING; Labeling	SUPPL	60	AP	2010-06-25	UNKNOWN
LABELING; Labeling	SUPPL	61	AP	2013-10-31	STANDARD
LABELING; Labeling	SUPPL	62	AP	2012-11-28	UNKNOWN
LABELING; Labeling	SUPPL	64	AP	2012-12-13	STANDARD
LABELING; Labeling	SUPPL	67	AP	2013-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	74	AP	2014-03-04	STANDARD
LABELING; Labeling	SUPPL	75	AP	2014-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	76	AP	2014-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	77	AP	2014-09-04	STANDARD
EFFICACY; Efficacy	SUPPL	78	AP	2015-01-14	STANDARD
LABELING; Labeling	SUPPL	79	AP	2017-03-16	STANDARD
LABELING; Labeling	SUPPL	80	AP	2015-01-23	STANDARD
LABELING; Labeling	SUPPL	81	AP	2015-02-25	901 REQUIRED
LABELING; Labeling	SUPPL	82	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	84	AP	2016-10-07	STANDARD
LABELING; Labeling	SUPPL	87	AP	2018-12-20	STANDARD
LABELING; Labeling	SUPPL	90	AP	2019-11-15	STANDARD
LABELING; Labeling	SUPPL	91	AP	2019-11-15	901 REQUIRED
LABELING; Labeling	SUPPL	93	AP	2021-03-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	95	AP	2021-10-22	N/A

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	23	Null	0
SUPPL	32	Null	31
SUPPL	33	Null	8
SUPPL	40	Null	0
SUPPL	55	Null	4
SUPPL	57	Null	15
SUPPL	58	Null	6
SUPPL	59	Null	6
SUPPL	60	Null	7
SUPPL	61	Null	7
SUPPL	62	Null	15
SUPPL	64	Null	7
SUPPL	67	Null	6
SUPPL	74	Null	0
SUPPL	75	Null	15
SUPPL	76	Null	0
SUPPL	77	Null	0
SUPPL	78	Null	15
SUPPL	79	Null	6
SUPPL	80	Null	6
SUPPL	81	Null	7
SUPPL	82	Null	7
SUPPL	84	Null	7
SUPPL	87	Null	6
SUPPL	90	Null	7
SUPPL	91	Null	15
SUPPL	93	Null	7

CDER Filings

NOVO NORDISK INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20986
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOVOLOG","activeIngredients":"INSULIN ASPART RECOMBINANT","strength":"1000 UNITS\/10ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOVOLOG FLEXPEN","activeIngredients":"INSULIN ASPART RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"NOVOLOG FLEXTOUCH","activeIngredients":"INSULIN ASPART RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NOVOLOG INNOLET","activeIngredients":"INSULIN ASPART RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NOVOLOG PENFILL","activeIngredients":"INSULIN ASPART RECOMBINANT","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-91","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020986s090s091lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-90","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020986s090s091lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-90","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020986s090s091lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20986lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NOVOLOG","submission":"INSULIN ASPART RECOMBINANT","actionType":"1000 UNITS\/10ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NOVOLOG FLEXPEN","submission":"INSULIN ASPART RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NOVOLOG FLEXTOUCH","submission":"INSULIN ASPART RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NOVOLOG INNOLET","submission":"INSULIN ASPART RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NOVOLOG PENFILL","submission":"INSULIN ASPART RECOMBINANT","actionType":"300 UNITS\/3ML (100 UNITS\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2019-11-15
        )

)