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FDA NDA · NDA209905

EVEKEO ODT

Sponsor: AZURITY

APPLICATION
NDA209905
TYPE
NDA
ORIGINAL APPROVAL
2019-01-30
LATEST ACTION
2023-10-13
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

EVEKEO ODT · ReferenceDiscontinued
AMPHETAMINE SULFATE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
EVEKEO ODT · ReferenceDiscontinued
AMPHETAMINE SULFATE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
EVEKEO ODT · ReferenceDiscontinued
AMPHETAMINE SULFATE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL
EVEKEO ODT · ReferenceDiscontinued
AMPHETAMINE SULFATE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
EVEKEO ODT · ReferenceDiscontinued
AMPHETAMINE SULFATE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2023-10-13Labeling · Supplement 4 · standard — Letter ↗AP
2022-09-30Labeling · Supplement 3 · standard — Letter ↗AP
2022-02-25Labeling · Supplement 2 · 901 required — Letter ↗AP
2021-04-16Efficacy · Supplement 1 · standard — Label ↗AP
2019-01-30Type 3 - New Dosage Form · Original · standard — Label ↗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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