← FDA DRUG APPROVALS

FDA NDA · NDA206406

ENVARSUS XR

tacrolimus

Sponsor: VELOXIS PHARMS INC

APPLICATION
NDA206406
TYPE
NDA
ORIGINAL APPROVAL
2015-07-10
LATEST ACTION
2024-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ENVARSUS XR · ReferencePrescription
TACROLIMUS EQ 1MG BASE · TABLET, EXTENDED RELEASE · ORAL
ENVARSUS XR · ReferencePrescription
TACROLIMUS EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
ENVARSUS XR · ReferencePrescription
TACROLIMUS EQ 0.75MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-04-08Labeling · Supplement 9 · standard — Letter ↗AP
2023-09-14Labeling · Supplement 10 · standard — Letter ↗AP
2020-09-16Labeling · Supplement 8 · standard — Letter ↗AP
2018-12-19Efficacy · Supplement 7 · standard — Label ↗AP
2017-01-06Manufacturing (CMC) · Supplement 5 · standardAP
2016-06-22Labeling · Supplement 3 · standard — Label ↗AP
2016-06-13Manufacturing (CMC) · Supplement 4 · standardAP
2016-06-07Manufacturing (CMC) · Supplement 2 · standardAP
2015-08-12Labeling · Supplement 1 · standard — Label ↗AP
2015-07-10Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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