← FDA DRUG APPROVALS

FDA NDA · NDA020738

TEVETEN

Sponsor: ABBVIE

APPLICATION
NDA020738
TYPE
NDA
ORIGINAL APPROVAL
1997-12-22
LATEST ACTION
2014-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TEVETEN · ReferenceDiscontinued
EPROSARTAN MESYLATE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TEVETEN · ReferenceDiscontinued
EPROSARTAN MESYLATE EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TEVETENDiscontinued
EPROSARTAN MESYLATE EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2014-07-22Labeling · Supplement 29 · standard — Label ↗AP
2012-09-12Labeling · Supplement 28 · unknown — Label ↗AP
2012-01-19Labeling · Supplement 27 · unknown — Label ↗AP
2011-05-03Labeling · Supplement 26 · unknown — Label ↗AP
2003-10-16Labeling · Supplement 12 · standard — Letter ↗AP
2001-10-29Manufacturing (CMC) · Supplement 10 · standardAP
2000-12-15Manufacturing (CMC) · Supplement 9 · standardAP
2000-05-08Manufacturing (CMC) · Supplement 8 · standardAP
1999-12-02Manufacturing (CMC) · Supplement 5 · standardAP
1999-11-05Manufacturing (CMC) · Supplement 7 · standardAP
1999-10-04Manufacturing (CMC) · Supplement 6 · standardAP
1999-05-27Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1998-10-28Efficacy · Supplement 1 · standard — Review ↗AP
1998-06-30Manufacturing (CMC) · Supplement 2 · standardAP
1998-05-21Manufacturing (CMC) · Supplement 3 · standardAP
1997-12-22Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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