← FDA DRUG APPROVALS

FDA NDA · NDA207695

EUCRISA

crisaborole

Sponsor: ANACOR PHARMS INC

APPLICATION
NDA207695
TYPE
NDA
ORIGINAL APPROVAL
2016-12-14
LATEST ACTION
2023-04-03
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription

Products

EUCRISA · ReferencePrescription
CRISABOROLE 2% · OINTMENT · TOPICAL

Approval history

2023-04-03Efficacy · Supplement 12 · standard — Letter ↗AP
2020-03-23Labeling · Supplement 9 · standard — Label ↗AP
2020-03-23Labeling · Supplement 7 · standard — Label ↗AP
2020-03-23Efficacy · Supplement 10 · priority — Label ↗AP
2017-10-16Labeling · Supplement 2 · standard — Letter ↗AP
2016-12-14Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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