← FDA DRUG APPROVALS

FDA NDA · NDA022401

TWYNSTA

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA022401
TYPE
NDA
ORIGINAL APPROVAL
2009-10-16
LATEST ACTION
2018-02-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TWYNSTA · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, TELMISARTAN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TWYNSTA · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, TELMISARTAN 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TWYNSTA · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, TELMISARTAN 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TWYNSTA · ReferenceDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, TELMISARTAN 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-02-01Labeling · Supplement 19 · standard — Label ↗AP
2016-01-13Labeling · Supplement 18 · standard — Label ↗AP
2015-11-19Manufacturing (CMC) · Supplement 17 · standardAP
2014-12-12Labeling · Supplement 16 · standard — Letter ↗AP
2014-12-11Manufacturing (CMC) · Supplement 14 · standardAP
2012-11-14Labeling · Supplement 12 · standard — Label ↗AP
2012-10-19Labeling · Supplement 9 · unknown — Label ↗AP
2012-10-19Labeling · Supplement 7 · unknown — Letter ↗AP
2012-03-29Labeling · Supplement 11 · standard — Letter ↗AP
2012-01-18Labeling · Supplement 4 · unknown — Label ↗AP
2011-11-14Labeling · Supplement 10 · unknown — Letter ↗AP
2011-06-06Labeling · Supplement 5 · unknown — Letter ↗AP
2010-07-27Labeling · Supplement 2 · unknown — Label ↗AP
2009-10-16Type 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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