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FDA BLA · BLA020986

INSULIN DILUTING MEDIUM FOR NOVOLOG

water injection

Sponsor: NOVO NORDISK INC

APPLICATION
BLA020986
TYPE
BLA
ORIGINAL APPROVAL
2000-06-07
LATEST ACTION
2023-02-28
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

NOVOLOG PENFILLPrescription
INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) · INJECTABLE · SUBCUTANEOUS
NOVOLOG FLEXTOUCHDiscontinued
INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) · INJECTABLE · SUBCUTANEOUS
NOVOLOG FLEXPENPrescription
INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) · INJECTABLE · SUBCUTANEOUS
NOVOLOGPrescription
INSULIN ASPART RECOMBINANT 1000 UNITS/10ML (100 UNITS/ML) · INJECTABLE · SUBCUTANEOUS
NOVOLOG INNOLETDiscontinued
INSULIN ASPART RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2023-02-28Labeling · Supplement 96 · standardLetterAP
2021-10-22Manufacturing (CMC) · Supplement 95LetterAP
2021-03-23Labeling · Supplement 93 · standardLetterAP
2019-11-15Labeling · Supplement 90 · standardLabelAP
2019-11-15Labeling · Supplement 91 · 901 requiredLabelAP
2018-12-20Labeling · Supplement 87 · standardLetterAP
2017-03-16Labeling · Supplement 79 · standardLabelAP
2016-10-07Labeling · Supplement 84 · standardLetterAP
2015-04-17Labeling · Supplement 82 · standardLabelAP
2015-02-25Labeling · Supplement 81 · 901 requiredLabelAP
2015-02-25Labeling · Supplement 59 · unknownLetterAP
2015-01-23Labeling · Supplement 80 · standardLabelAP
2015-01-14Efficacy · Supplement 78 · standardLetterAP
2014-09-04Manufacturing (CMC) · Supplement 76 · standardAP
2014-09-04Manufacturing (CMC) · Supplement 77 · standardAP
2014-03-04Manufacturing (CMC) · Supplement 74 · standardAP
2014-02-25Labeling · Supplement 75 · standardLetterAP
2013-10-31Labeling · Supplement 61 · standardLabelAP
2013-03-09Labeling · Supplement 67 · standardLetterAP
2012-12-13Labeling · Supplement 64 · standardLetterAP
2012-11-28Labeling · Supplement 62 · unknownLetterAP
2012-11-05Labeling · Supplement 57 · standardLabelAP
2010-06-25Manufacturing (CMC) · Supplement 58LetterAP
2010-06-25Labeling · Supplement 60 · unknownLetterAP
2009-07-17Manufacturing (CMC) · Supplement 55LabelAP
2009-07-14Manufacturing (CMC) · Supplement 45LabelAP
2009-05-07Labeling · Supplement 54 · standardLetterAP
2008-11-28Labeling · Supplement 53 · standardLetterAP
2008-09-03Labeling · Supplement 50 · standardLetterAP
2008-09-03Labeling · Supplement 49 · standardLetterAP
2008-03-14Efficacy · Supplement 47 · standardLabelAP
2007-01-26Efficacy · Supplement 37 · unknownLabelAP
2006-10-27Manufacturing (CMC) · Supplement 40 · standardReviewAP
2005-10-21Efficacy · Supplement 32 · unknownLabelAP
2005-09-13Efficacy · Supplement 33 · priorityLetterAP
2004-10-08Labeling · Supplement 19 · standardLetterAP
2004-07-30Labeling · Supplement 24 · standardLetterAP
2004-04-23Manufacturing (CMC) · Supplement 23 · standardLetterAP
2004-03-19Labeling · Supplement 20 · standardLabelAP
2002-12-04Efficacy · Supplement 11 · standardLabelAP
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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