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FDA NDA · NDA208379

ZYPITAMAG

pitavastatin magnesium

Sponsor: MEDICURE

APPLICATION
NDA208379
TYPE
NDA
ORIGINAL APPROVAL
2017-07-14
LATEST ACTION
2024-01-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

ZYPITAMAG · ReferencePrescription
PITAVASTATIN MAGNESIUM EQ 4MG BASE · TABLET · ORAL
ZYPITAMAG · ReferenceDiscontinued
PITAVASTATIN MAGNESIUM EQ 1MG BASE · TABLET · ORAL
ZYPITAMAG · ReferencePrescription
PITAVASTATIN MAGNESIUM EQ 2MG BASE · TABLET · ORAL

Approval history

2024-01-31Labeling · Supplement 5 · standard — Letter ↗AP
2020-09-25Labeling · Supplement 4 · 901 required — Letter ↗AP
2020-02-07Labeling · Supplement 3 · standard — Label ↗AP
2017-07-14Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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