← FDA DRUG APPROVALS

FDA NDA · NDA021232

ORFADIN

nitisinone

Sponsor: SWEDISH ORPHAN

APPLICATION
NDA021232
TYPE
NDA
ORIGINAL APPROVAL
2002-01-18
LATEST ACTION
2019-05-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ORFADIN · ReferencePrescription
NITISINONE 20MG · CAPSULE · ORAL
ORFADIN · ReferencePrescription
NITISINONE 5MG · CAPSULE · ORAL
ORFADIN · ReferencePrescription
NITISINONE 10MG · CAPSULE · ORAL
ORFADIN · ReferencePrescription
NITISINONE 2MG · CAPSULE · ORAL

Approval history

2019-05-17Labeling · Supplement 23 · standard — Letter ↗AP
2017-09-01Efficacy · Supplement 20 · standard — Label ↗AP
2017-02-28Manufacturing (CMC) · Supplement 19 — Label ↗AP
2016-06-13Manufacturing (CMC) · Supplement 17 · priority — Label ↗AP
2015-06-05Manufacturing (CMC) · Supplement 16 · priorityAP
2014-10-30Manufacturing (CMC) · Supplement 14 · priorityAP
2014-10-27Manufacturing (CMC) · Supplement 15 · priorityAP
2014-05-21Labeling · Supplement 13 · standard — Label ↗AP
2013-06-21Manufacturing (CMC) · Supplement 12 · priorityAP
2013-04-02Manufacturing (CMC) · Supplement 11 · priorityAP
2013-02-13Labeling · Supplement 10 · standard — Letter ↗AP
2010-01-25Labeling · Supplement 8 · standard — Letter ↗AP
2002-01-18Type 1 - New Molecular Entity · Original · priority — Label ↗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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