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FDA NDA · NDA209875

NIKITA

Sponsor: LUPIN

APPLICATION
NDA209875
TYPE
NDA
ORIGINAL APPROVAL
2017-08-04
LATEST ACTION
2023-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NIKITA · ReferenceDiscontinued
PITAVASTATIN SODIUM EQ 2MG BASE · TABLET · ORAL
NIKITA · ReferenceDiscontinued
PITAVASTATIN SODIUM EQ 4MG BASE · TABLET · ORAL
NIKITA · ReferenceDiscontinued
PITAVASTATIN SODIUM EQ 1MG BASE · TABLET · ORAL

Approval history

2023-10-30Labeling · Supplement 3 · standard — Label ↗AP
2020-09-25Labeling · Supplement 2 · 901 required — Letter ↗AP
2020-05-05Labeling · Supplement 1 · standard — Letter ↗AP
2017-08-04Type 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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