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FDA NDA · NDA020850

MICARDIS

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA020850
TYPE
NDA
ORIGINAL APPROVAL
1998-11-10
LATEST ACTION
2022-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MICARDIS · ReferenceDiscontinued
TELMISARTAN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MICARDIS · ReferenceDiscontinued
TELMISARTAN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MICARDIS · ReferenceDiscontinued
TELMISARTAN 40MG · TABLET · ORAL

Approval history

2022-12-19Labeling · Supplement 45 · standard — Letter ↗AP
2018-02-01Labeling · Supplement 40 · standard — Label ↗AP
2015-08-05Manufacturing (CMC) · Supplement 39 · standardAP
2015-02-16Manufacturing (CMC) · Supplement 37 · standardAP
2014-12-12Labeling · Supplement 38 · standard — Letter ↗AP
2012-10-24Labeling · Supplement 36 · standard — Letter ↗AP
2012-09-20Labeling · Supplement 33 · unknown — Letter ↗AP
2012-01-19Labeling · Supplement 35 · unknown — Label ↗AP
2012-01-18Labeling · Supplement 31 · unknown — Label ↗AP
2011-07-06Labeling · Supplement 32 · unknown — Letter ↗AP
2009-10-16Efficacy · Supplement 25 · standard — Label ↗AP
2009-08-11Labeling · Supplement 23 · standard — Label ↗AP
2009-08-11Labeling · Supplement 22 · standard — Label ↗AP
2007-02-27Labeling · Supplement 19 · standard — Letter ↗AP
2005-09-02Labeling · Supplement 13 · standard — Label ↗AP
2004-03-30Labeling · Supplement 11 · standard — Letter ↗AP
2003-10-23Labeling · Supplement 5 · standard — Letter ↗AP
2000-10-12Manufacturing (CMC) · Supplement 4 · standardAP
2000-04-04Manufacturing (CMC) · Supplement 3 · standardAP
1999-12-02Manufacturing (CMC) · Supplement 2 · standardAP
1999-10-29Manufacturing (CMC) · Supplement 1 · standardAP
1998-11-10Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
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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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