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FDA NDA · NDA021956

DUTOPROL

Sponsor: CONCORDIA

APPLICATION
NDA021956
TYPE
NDA
ORIGINAL APPROVAL
2006-08-28
LATEST ACTION
2022-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DUTOPROL · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, METOPROLOL SUCCINATE EQ 100MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
DUTOPROL · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, METOPROLOL SUCCINATE EQ 25MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
DUTOPROL · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, METOPROLOL SUCCINATE EQ 50MG TARTRATE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-01-14Labeling · Supplement 11 · standard — Letter ↗AP
2020-08-20Labeling · Supplement 12 · standard — Letter ↗AP
2017-08-16Labeling · Supplement 10 · standard — Label ↗AP
2016-06-06Manufacturing (CMC) · Supplement 8 · standardAP
2014-12-02Manufacturing (CMC) · Supplement 7 · standardAP
2014-10-20Labeling · Supplement 4 · standard — Label ↗AP
2011-12-19Labeling · Supplement 3 · unknown — Label ↗AP
2011-03-02Labeling · Supplement 1 · unknown — Letter ↗AP
2011-03-02Labeling · Supplement 2 · unknown — Label ↗AP
2006-08-28Type 4 - New Combination · Original · standard — Letter ↗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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