← FDA DRUG APPROVALS

FDA BLA · BLA021172

INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30

insulin aspart

Sponsor: NOVO NORDISK INC

APPLICATION
BLA021172
TYPE
BLA
ORIGINAL APPROVAL
2001-11-01
LATEST ACTION
2023-02-28
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

NOVOLOG MIX 70/30 PENFILLDiscontinued
INSULIN ASPART PROTAMINE RECOMBINANT 210 UNITS/3ML, INSULIN ASPART RECOMBINANT 90 UNITS/3ML (70 UNITS/ML · INJECTABLE · SUBCUTANEOUS
NOVOLOG MIX 70/30Prescription
INSULIN ASPART PROTAMINE RECOMBINANT 700 UNITS/10ML, INSULIN ASPART RECOMBINANT 300 UNITS/10ML (70 UNITS/ML · INJECTABLE · SUBCUTANEOUS
NOVOLOG MIX 70/30 FLEXPENPrescription
INSULIN ASPART PROTAMINE RECOMBINANT 210 UNITS/3ML, INSULIN ASPART RECOMBINANT 90 UNITS/3ML (70 UNITS/ML · INJECTABLE · SUBCUTANEOUS
NOVOLOG MIX 70/30 PENFILLDiscontinued
INSULIN ASPART PROTAMINE RECOMBINANT 210 UNITS/3ML, INSULIN ASPART RECOMBINANT 90 UNITS/3ML (70 UNITS/ML · INJECTABLE · SUBCUTANEOUS

Approval history

2023-02-28Labeling · Supplement 76 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 74 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 72 · 901 required — Letter ↗AP
2019-11-15Labeling · Supplement 71 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 68 · standard — Label ↗AP
2017-05-08Labeling · Supplement 62 · standard — Letter ↗AP
2015-04-17Labeling · Supplement 64 · standard — Letter ↗AP
2015-02-25Labeling · Supplement 46 · standard — Label ↗AP
2015-02-25Labeling · Supplement 63 · 901 required — Letter ↗AP
2014-09-04Manufacturing (CMC) · Supplement 61 · standardAP
2013-03-09Labeling · Supplement 53 · standard — Label ↗AP
2012-12-13Labeling · Supplement 51 · standard — Label ↗AP
2010-05-07Efficacy · Supplement 49 · standard — Label ↗AP
2010-05-07Efficacy · Supplement 45 · standard — Label ↗AP
2009-05-07Labeling · Supplement 44 · standard — Letter ↗AP
2008-11-28Labeling · Supplement 43 · standard — Letter ↗AP
2008-09-03Labeling · Supplement 38 · standard — Letter ↗AP
2008-09-03Labeling · Supplement 39 · standard — Letter ↗AP
2007-07-20Manufacturing (CMC) · Supplement 34 — Label ↗AP
2005-11-21Efficacy · Supplement 21 · unknown — Letter ↗AP
2005-11-14Labeling · Supplement 23 · standard — Label ↗AP
2004-10-08Labeling · Supplement 13 · standard — Letter ↗AP
2002-12-04Manufacturing (CMC) · Supplement 11 · standardAP
2002-11-19Manufacturing (CMC) · Supplement 10 · standardAP
2002-11-18Manufacturing (CMC) · Supplement 9 · standard — Letter ↗AP
2002-07-29Manufacturing (CMC) · Supplement 8 · standardAP
2002-06-26Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
2002-05-03Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2002-03-05Manufacturing (CMC) · Supplement 7 · standardAP
2002-02-25Manufacturing (CMC) · Supplement 4 · standardAP
2002-02-25Manufacturing (CMC) · Supplement 2 · standardAP
2002-02-25Manufacturing (CMC) · Supplement 5 · standardAP
2002-02-25Manufacturing (CMC) · Supplement 6 · standardAP
2001-11-01Type 4 - New Combination · Original · priority — Letter ↗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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