← FDA DRUG APPROVALS

FDA BLA · BLA019938

NOVOLIN R

human insulin

Sponsor: NOVO NORDISK INC

APPLICATION
BLA019938
TYPE
BLA
ORIGINAL APPROVAL
1991-06-25
LATEST ACTION
2022-11-23
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Over-the-counter

Products

NOVOLIN ROver-the-counter
INSULIN RECOMBINANT HUMAN 100 UNITS/ML · INJECTABLE · INJECTION

Approval history

2022-11-23Labeling · Supplement 82 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 79 · 901 required — Label ↗AP
2018-06-01Labeling · Supplement 76 · standard — Label ↗AP
2016-11-18Manufacturing (CMC) · Supplement 75 · standardAP
2016-01-08Labeling · Supplement 74 · standard — Label ↗AP
2015-12-01Manufacturing (CMC) · Supplement 73 · standardAP
2013-03-09Labeling · Supplement 71 · standard — Label ↗AP
2013-02-07Labeling · Supplement 72 · standard — Label ↗AP
2012-02-27Labeling · Supplement 66 · standard — Label ↗AP
2010-12-27Labeling · Supplement 68 · standard — Letter ↗AP
2010-06-25Labeling · Supplement 69 · unknown — Letter ↗AP
2010-06-25Manufacturing (CMC) · Supplement 67 — Letter ↗AP
2009-07-17Manufacturing (CMC) · Supplement 64 — Label ↗AP
2009-06-15Labeling · Supplement 63 · standard — Label ↗AP
2005-11-18Labeling · Supplement 37 · standard — Label ↗AP
2005-10-21Efficacy · Supplement 48 · unknown — Label ↗AP
2002-06-19Manufacturing (CMC) · Supplement 36 · standardAP
2002-04-15Manufacturing (CMC) · Supplement 33 · standard — Label ↗AP
2002-04-11Manufacturing (CMC) · Supplement 32 · standard — Label ↗AP
2002-03-11Labeling · Supplement 30 · standard — Letter ↗AP
2002-01-10Manufacturing (CMC) · Supplement 35 · standardAP
2001-12-19Manufacturing (CMC) · Supplement 34 · standardAP
2001-12-10Labeling · Supplement 29 · standardAP
2001-01-09Manufacturing (CMC) · Supplement 31 · standardAP
2000-06-15Labeling · Supplement 27 · standardAP
2000-04-10Manufacturing (CMC) · Supplement 26 · standardAP
2000-03-16Manufacturing (CMC) · Supplement 25 · standardAP
1999-10-18Manufacturing (CMC) · Supplement 24 · standardAP
1998-07-24Manufacturing (CMC) · Supplement 23 · standardAP
1997-08-04Manufacturing (CMC) · Supplement 22 · standardAP
1997-06-20Manufacturing (CMC) · Supplement 21 · standardAP
1997-04-16Labeling · Supplement 20 · standard — Review ↗AP
1997-04-10Labeling · Supplement 19 · standard — Review ↗AP
1997-01-28Manufacturing (CMC) · Supplement 17 · standardAP
1996-06-13Manufacturing (CMC) · Supplement 18 · standardAP
1995-08-16Manufacturing (CMC) · Supplement 16 · standardAP
1995-05-22Manufacturing (CMC) · Supplement 15 · standardAP
1994-06-23Manufacturing (CMC) · Supplement 12 · standardAP
1994-06-23Manufacturing (CMC) · Supplement 11 · standardAP
1994-06-16Manufacturing (CMC) · Supplement 10 · standardAP
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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