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FDA NDA · NDA020482

PRECOSE

Sponsor: BAYER HLTHCARE

APPLICATION
NDA020482
TYPE
NDA
ORIGINAL APPROVAL
1995-09-06
LATEST ACTION
2015-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PRECOSE · ReferenceDiscontinued
ACARBOSE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRECOSE · ReferenceDiscontinued
ACARBOSE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRECOSE · ReferenceDiscontinued
ACARBOSE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2015-03-09Labeling · Supplement 27 · standard — Letter ↗AP
2014-11-11Manufacturing (CMC) · Supplement 26 · standardAP
2012-02-29Labeling · Supplement 25 · standard — Letter ↗AP
2011-03-24Labeling · Supplement 24 · unknown — Letter ↗AP
2008-08-23Labeling · Supplement 23 · standard — Letter ↗AP
2005-07-29Labeling · Supplement 15 · standard — Letter ↗AP
2002-10-29Labeling · Supplement 11 · standard — Letter ↗AP
2000-06-27Manufacturing (CMC) · Supplement 12 · standardAP
1999-08-16Efficacy · Supplement 10 · standard — Review ↗AP
1998-09-29Efficacy · Supplement 7 · standard — Review ↗AP
1998-09-29Efficacy · Supplement 8 · unknown — Review ↗AP
1998-02-04Labeling · Supplement 9 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 6 · standardAP
1997-10-10Manufacturing (CMC) · Supplement 5 · standardAP
1997-05-29Manufacturing (CMC) · Supplement 4 · standardAP
1996-12-13Labeling · Supplement 3 · standardAP
1996-01-16Labeling · Supplement 1 · standardAP
1995-09-06Type 1 - New Molecular Entity · 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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