← FDA DRUG APPROVALS

FDA NDA · NDA021162

MICARDIS HCT

telmisartan and hydrochlorothiazide

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA021162
TYPE
NDA
ORIGINAL APPROVAL
2000-11-17
LATEST ACTION
2022-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MICARDIS HCT · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 80MG · TABLET · ORAL
MICARDIS HCT · ReferencePrescription
HYDROCHLOROTHIAZIDE 25MG, TELMISARTAN 80MG · TABLET · ORAL
MICARDIS HCT · ReferencePrescription
HYDROCHLOROTHIAZIDE 12.5MG, TELMISARTAN 40MG · TABLET · ORAL

Approval history

2022-12-19Labeling · Supplement 47 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 45 · standard — Label ↗AP
2018-02-01Labeling · Supplement 40 · standard — Label ↗AP
2016-01-12Labeling · Supplement 32 · unknown — Letter ↗AP
2014-12-12Labeling · Supplement 37 · standard — Label ↗AP
2012-10-24Labeling · Supplement 35 · standard — Letter ↗AP
2012-01-20Labeling · Supplement 30 · unknown — Letter ↗AP
2012-01-19Labeling · Supplement 34 · unknown — Letter ↗AP
2011-05-12Labeling · Supplement 29 · unknown — Label ↗AP
2011-05-12Labeling · Supplement 31 · unknown — Label ↗AP
2009-08-11Labeling · Supplement 19 · standard — Letter ↗AP
2009-08-11Labeling · Supplement 20 · standard — Label ↗AP
2007-02-27Labeling · Supplement 16 · standard — Letter ↗AP
2005-09-02Labeling · Supplement 8 · standard — Label ↗AP
2004-04-19Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2000-11-17Type 4 - New Combination · Original · standard — Review ↗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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