← FDA DRUG APPROVALS

FDA NDA · NDA020741

PRANDIN

Sponsor: GEMINI LABS LLC

APPLICATION
NDA020741
TYPE
NDA
ORIGINAL APPROVAL
1997-12-22
LATEST ACTION
2019-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PRANDIN · ReferenceDiscontinued
REPAGLINIDE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRANDIN · ReferenceDiscontinued
REPAGLINIDE 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRANDIN · ReferenceDiscontinued
REPAGLINIDE 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-01-22Labeling · Supplement 44 · standard — Label ↗AP
2017-02-08Labeling · Supplement 41 · unknown — Label ↗AP
2017-02-08Labeling · Supplement 42 · standard — Label ↗AP
2015-10-30Manufacturing (CMC) · Supplement 43 · priorityAP
2012-03-01Labeling · Supplement 40 · standard — Label ↗AP
2010-07-29Labeling · Supplement 38 · unknown — Label ↗AP
2009-06-10Labeling · Supplement 35 · standard — Letter ↗AP
2008-07-14Labeling · Supplement 34 · standard — Label ↗AP
2006-06-19Labeling · Supplement 30 · standard — Letter ↗AP
2005-02-10Labeling · Supplement 22 · standard — Label ↗AP
2003-10-15Manufacturing (CMC) · Supplement 19 · priority — Review ↗AP
2003-08-27Labeling · Supplement 18 · standard — Label ↗AP
2002-11-25Manufacturing (CMC) · Supplement 16 · priority — Review ↗AP
2002-10-21Efficacy · Supplement 13 · standard — Label ↗AP
2002-10-01Manufacturing (CMC) · Supplement 15 · priority — Review ↗AP
2002-08-05Manufacturing (CMC) · Supplement 14 · priorityAP
2002-01-18Efficacy · Supplement 12 · standard — Label ↗AP
2000-10-27Manufacturing (CMC) · Supplement 10 · priorityAP
2000-08-15Manufacturing (CMC) · Supplement 9 · priority — Review ↗AP
2000-02-25Manufacturing (CMC) · Supplement 8 · priorityAP
1999-12-08Manufacturing (CMC) · Supplement 6 · priorityAP
1999-11-26Manufacturing (CMC) · Supplement 7 · priorityAP
1999-08-30Manufacturing (CMC) · Supplement 5 · priorityAP
1999-08-10Labeling · Supplement 1 · standardAP
1999-05-18Manufacturing (CMC) · Supplement 3 · priorityAP
1999-05-18Manufacturing (CMC) · Supplement 4 · priorityAP
1999-03-01Manufacturing (CMC) · Supplement 2 · priorityAP
1997-12-22Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →