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FDA BLA · BLA021810

NOVOLOG MIX 50/50

Sponsor: NOVO NORDISK INC

APPLICATION
BLA021810
TYPE
BLA
ORIGINAL APPROVAL
2008-08-26
LATEST ACTION
2019-11-15
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NOVOLOG MIX 50/50Discontinued
INSULIN ASPART PROTAMINE RECOMBINANT 50 UNITS/ML, INSULIN ASPART RECOMBINANT 50 UNITS/ML · INJECTABLE · SUBCUTANEOUS

Approval history

2019-11-15Labeling · Supplement 19 · 901 required — Letter ↗AP
2019-11-15Labeling · Supplement 18 · standard — Label ↗AP
2019-08-07Labeling · Supplement 17 · standard — Letter ↗AP
2019-02-11Labeling · Supplement 15 · standard — Letter ↗AP
2017-11-21Labeling · Supplement 1 · standard — Label ↗AP
2015-02-25Labeling · Supplement 10 · 901 required — Label ↗AP
2014-09-04Manufacturing (CMC) · Supplement 8 · standardAP
2013-03-09Labeling · Supplement 4 · standard — Label ↗AP
2008-08-26Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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