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FDA NDA · NDA020381

NIASPAN TITRATION STARTER PACK

Sponsor: ABBVIE

APPLICATION
NDA020381
TYPE
NDA
ORIGINAL APPROVAL
1997-07-28
LATEST ACTION
2022-05-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

NIASPAN TITRATION STARTER PACKDiscontinued
NIACIN 375MG · TABLET, EXTENDED RELEASE · ORAL
NIASPAN · ReferenceDiscontinued
NIACIN 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
NIASPANDiscontinued
NIACIN 375MG · TABLET, EXTENDED RELEASE · ORAL
NIASPAN · ReferenceDiscontinued
NIACIN 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
NIASPAN · ReferenceDiscontinued
NIACIN 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-05-02Labeling · Supplement 55 · standard — Letter ↗AP
2020-09-09Labeling · Supplement 54 · standard — Letter ↗AP
2015-10-28Manufacturing (CMC) · Supplement 52 · standardAP
2015-05-27Manufacturing (CMC) · Supplement 50 · standardAP
2015-04-27Labeling · Supplement 51 · standard — Letter ↗AP
2013-06-18Manufacturing (CMC) · Supplement 49 · standardAP
2013-02-21Labeling · Supplement 48 · unknown — Letter ↗AP
2010-11-09Labeling · Supplement 43 · unknown — Label ↗AP
2010-02-24Labeling · Supplement 42 · unknown — Label ↗AP
2009-09-16Manufacturing (CMC) · Supplement 39 — Label ↗AP
2009-09-16Manufacturing (CMC) · Supplement 41 — Letter ↗AP
2009-03-26Labeling · Supplement 38 · standard — Letter ↗AP
2008-05-29Labeling · Supplement 32 · standard — Letter ↗AP
2007-12-18Labeling · Supplement 34 · standard — Letter ↗AP
2007-04-04Manufacturing (CMC) · Supplement 27 · standard — Letter ↗AP
2006-04-11Labeling · Supplement 25 · standard — Letter ↗AP
2005-09-09Manufacturing (CMC) · Supplement 23 · standard — Letter ↗AP
2005-06-08Labeling · Supplement 20 · standard — Label ↗AP
2003-01-31Efficacy · Supplement 13 · standard — Letter ↗AP
2002-09-05Manufacturing (CMC) · Supplement 14 · standardAP
2000-11-24Manufacturing (CMC) · Supplement 12 · standardAP
2000-08-02Manufacturing (CMC) · Supplement 10 · standardAP
2000-08-02Manufacturing (CMC) · Supplement 11 · standardAP
2000-06-09Manufacturing (CMC) · Supplement 9 · standardAP
2000-05-08Manufacturing (CMC) · Supplement 8 · standardAP
1999-10-28Efficacy · Supplement 6 · standard — Letter ↗AP
1999-09-13Efficacy · Supplement 7 · standard — Letter ↗AP
1998-08-24Manufacturing (CMC) · Supplement 4 · standardAP
1998-05-12Manufacturing (CMC) · Supplement 3 · standardAP
1998-03-23Manufacturing (CMC) · Supplement 1 · standardAP
1998-03-02Manufacturing (CMC) · Supplement 2 · standardAP
1997-07-28Type 3 - New Dosage Form · Original · standardAP
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