← FDA DRUG APPROVALS

FDA NDA · NDA204096

ASTAGRAF XL

tacrolimus extended-release capsules

Sponsor: ASTELLAS

APPLICATION
NDA204096
TYPE
NDA
ORIGINAL APPROVAL
2013-07-19
LATEST ACTION
2023-09-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ASTAGRAF XL · ReferencePrescription
TACROLIMUS EQ 5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
ASTAGRAF XL · ReferencePrescription
TACROLIMUS EQ 0.5MG BASE · CAPSULE, EXTENDED RELEASE · ORAL
ASTAGRAF XL · ReferencePrescription
TACROLIMUS EQ 1MG BASE · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2023-09-14Labeling · Supplement 11 · standard — Letter ↗AP
2022-11-22Labeling · Supplement 10 · standard — Label ↗AP
2020-12-30Labeling · Supplement 9 · standard — Letter ↗AP
2019-06-11Labeling · Supplement 7 · standard — Letter ↗AP
2018-11-29Efficacy · Supplement 5 · standard — Label ↗AP
2015-12-16Labeling · Supplement 4 · standard — Label ↗AP
2015-12-16Labeling · Supplement 3 · standard — Label ↗AP
2014-02-28Labeling · Supplement 2 · standard — Label ↗AP
2014-02-11Labeling · Supplement 1 · standard — Letter ↗AP
2013-07-19Type 3 - New Dosage Form · Original · standard — Summary Review ↗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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