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FDA NDA · NDA213072

ROSZET

Sponsor: ALTHERA PHARMS

APPLICATION
NDA213072
TYPE
NDA
ORIGINAL APPROVAL
2021-03-23
LATEST ACTION
2024-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ROSZET · ReferenceDiscontinued
EZETIMIBE 10MG, ROSUVASTATIN CALCIUM EQ 20MG BASE · TABLET · ORAL
ROSZET · ReferenceDiscontinued
EZETIMIBE 10MG, ROSUVASTATIN CALCIUM EQ 5MG BASE · TABLET · ORAL
ROSZET · ReferenceDiscontinued
EZETIMIBE 10MG, ROSUVASTATIN CALCIUM EQ 40MG BASE · TABLET · ORAL
ROSZET · ReferenceDiscontinued
EZETIMIBE 10MG, ROSUVASTATIN CALCIUM EQ 10MG BASE · TABLET · ORAL

Approval history

2024-08-26Efficacy · Supplement 4 · standard — Letter ↗AP
2021-03-23Type 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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