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FDA NDA · NDA210115

PROGRAF

tacrolimus

Sponsor: ASTELLAS

APPLICATION
NDA210115
TYPE
NDA
ORIGINAL APPROVAL
2018-05-24
LATEST ACTION
2023-09-14
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

PROGRAF · ReferencePrescription
TACROLIMUS EQ 0.2MG BASE/PACKET · FOR SUSPENSION · ORAL
PROGRAF · ReferencePrescription
TACROLIMUS EQ 1MG BASE/PACKET · FOR SUSPENSION · ORAL

Approval history

2023-09-14Labeling · Supplement 7 · standard — Letter ↗AP
2022-11-22Labeling · Supplement 6 · standard — Label ↗AP
2021-07-16Efficacy · Supplement 5 · priority — Label ↗AP
2020-12-30Labeling · Supplement 4 · standard — Letter ↗AP
2019-06-11Labeling · Supplement 2 · standard — Label ↗AP
2018-12-02Labeling · Supplement 1 · standard — Letter ↗AP
2018-05-24Type 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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