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FDA NDA · NDA050757

PREVPAC (COPACKAGED)

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA050757
TYPE
NDA
ORIGINAL APPROVAL
1997-12-02
LATEST ACTION
2018-06-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Discontinued

Products

PREVPAC (COPACKAGED) · ReferenceDiscontinued
AMOXICILLIN 500MG, CLARITHROMYCIN 500MG, LANSOPRAZOLE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2018-06-07Labeling · Supplement 22 · standard — Label ↗AP
2017-11-29Labeling · Supplement 21 · standard — Label ↗AP
2017-03-01Labeling · Supplement 18 · standard — Label ↗AP
2016-10-24Labeling · Supplement 20 · 901 required — Letter ↗AP
2014-12-19Labeling · Supplement 19 · 901 required — Letter ↗AP
2013-11-06Labeling · Supplement 17 · unknown — Label ↗AP
2009-04-01Labeling · Supplement 16 · standard — Letter ↗AP
2007-10-30Labeling · Supplement 15 · standard — Letter ↗AP
2007-05-31Labeling · Supplement 14 · standard — Letter ↗AP
2006-08-09Labeling · Supplement 12 · standard — Letter ↗AP
2006-08-09Labeling · Supplement 13 · standard — Letter ↗AP
2005-04-20Labeling · Supplement 11 · standard — Label ↗AP
2004-07-27Labeling · Supplement 9 · standard — Letter ↗AP
2004-07-27Labeling · Supplement 10 · standard — Letter ↗AP
2002-11-22Labeling · Supplement 8 · standard — Label ↗AP
2002-11-22Labeling · Supplement 6 · standard — Letter ↗AP
2002-03-12Manufacturing (CMC) · Supplement 7 · standardAP
2001-02-27Manufacturing (CMC) · Supplement 5 · standardAP
1999-10-22Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1999-08-20Manufacturing (CMC) · Supplement 3 · standard — Label ↗AP
1999-01-22Efficacy · Supplement 2 · standard — Label ↗AP
1998-01-09Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-02Type 4 - New Combination · Original · standard — Review ↗AP
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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