← FDA DRUG APPROVALS

FDA NDA · NDA050777

TACROLIMUS

Sponsor: LEO PHARMA AS

APPLICATION
NDA050777
TYPE
NDA
ORIGINAL APPROVAL
2000-12-08
LATEST ACTION
2019-02-25
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

PROTOPIC · ReferencePrescription
TACROLIMUS 0.1% · OINTMENT · TOPICAL
PROTOPIC · ReferencePrescription
TACROLIMUS 0.03% · OINTMENT · TOPICAL

Approval history

2019-02-25Manufacturing (CMC) · Supplement 21 — Label ↗AP
2011-11-04Labeling · Supplement 18 · unknown — Label ↗AP
2008-12-31Manufacturing (CMC) · Supplement 14 — Letter ↗AP
2006-01-19Labeling · Supplement 12 · standard — Label ↗AP
2005-07-14Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2003-12-23Manufacturing (CMC) · Supplement 6 · standard — Label ↗AP
2003-04-18Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2002-11-22Manufacturing (CMC) · Supplement 3 · standardAP
2002-06-13Manufacturing (CMC) · Supplement 2 · standardAP
2001-06-26Manufacturing (CMC) · Supplement 1 · standardAP
2000-12-08Type 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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