← FDA DRUG APPROVALS

FDA NDA · NDA018422

LOPID

gemfibrozil

Sponsor: PFIZER PHARMS

APPLICATION
NDA018422
TYPE
NDA
ORIGINAL APPROVAL
1981-12-21
LATEST ACTION
2020-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

LOPID · ReferencePrescription
GEMFIBROZIL 600MG · TABLET · ORAL
LOPIDDiscontinued
GEMFIBROZIL 200MG · CAPSULE · ORAL
LOPIDDiscontinued
GEMFIBROZIL 300MG · CAPSULE · ORAL

Approval history

2020-12-10Labeling · Supplement 59 · standard — Label ↗AP
2018-04-25Labeling · Supplement 58 · standard — Label ↗AP
2017-04-18Labeling · Supplement 56 · standard — Label ↗AP
2016-04-06Labeling · Supplement 55 · standard — Letter ↗AP
2014-11-05Labeling · Supplement 54 · standard — Letter ↗AP
2013-10-31Labeling · Supplement 53 · standard — Label ↗AP
2010-09-27Labeling · Supplement 50 · standard — Label ↗AP
2009-07-14Labeling · Supplement 48 · standard — Letter ↗AP
2004-03-30Labeling · Supplement 45 · standard — Letter ↗AP
2003-01-15Labeling · Supplement 43 · standard — Letter ↗AP
2002-09-26Manufacturing (CMC) · Supplement 42 · standardAP
2001-08-07Labeling · Supplement 40 · standard — Letter ↗AP
2001-08-07Labeling · Supplement 41 · standard — Label ↗AP
1998-12-03Labeling · Supplement 34 · standardAP
1997-07-18Manufacturing (CMC) · Supplement 39 · standardAP
1995-03-24Labeling · Supplement 37 · standardAP
1995-03-24Labeling · Supplement 35 · standardAP
1995-03-24Labeling · Supplement 33 · standardAP
1992-12-02Labeling · Supplement 32 · standardAP
1992-03-16Labeling · Supplement 31AP
1990-06-04Labeling · Supplement 26AP
1990-01-29Manufacturing (CMC) · Supplement 30 · standardAP
1990-01-03Manufacturing (CMC) · Supplement 29 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 28 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 27 · standardAP
1989-01-17Efficacy · Supplement 22AP
1988-12-01Manufacturing (CMC) · Supplement 23 · standardAP
1988-11-15Manufacturing (CMC) · Supplement 24 · standardAP
1988-05-25Manufacturing (CMC) · Supplement 21 · standardAP
1988-02-03Manufacturing (CMC) · Supplement 20 · standardAP
1988-02-03Manufacturing (CMC) · Supplement 19 · standardAP
1988-01-28Manufacturing (CMC) · Supplement 17 · standardAP
1987-11-03Manufacturing (CMC) · Supplement 18 · standardAP
1987-11-03Manufacturing (CMC) · Supplement 16 · standardAP
1987-08-26Manufacturing (CMC) · Supplement 14 · standardAP
1986-11-20Manufacturing (CMC) · Supplement 8 · standardAP
1986-04-04Labeling · Supplement 12AP
1985-12-20Manufacturing (CMC) · Supplement 10 · standardAP
1985-12-10Manufacturing (CMC) · Supplement 11 · standardAP
1984-08-22Manufacturing (CMC) · Supplement 5 · standardAP
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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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