← FDA DRUG APPROVALS

FDA NDA · NDA022181

KUVAN

sapropterin dihydrochloride

Sponsor: BIOMARIN PHARM

APPLICATION
NDA022181
TYPE
NDA
ORIGINAL APPROVAL
2007-12-13
LATEST ACTION
2024-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KUVAN · ReferencePrescription
SAPROPTERIN DIHYDROCHLORIDE 100MG · TABLET · ORAL

Approval history

2024-08-26Labeling · Supplement 24 · standard — Letter ↗AP
2020-03-16Labeling · Supplement 20 · standard — Label ↗AP
2019-12-13Labeling · Supplement 18 · standard — Label ↗AP
2019-05-02Labeling · Supplement 19 · standard — Label ↗AP
2019-02-01Labeling · Supplement 17 · standard — Label ↗AP
2016-06-13Labeling · Supplement 14 · standard — Label ↗AP
2014-04-23Efficacy · Supplement 13 · priority — Label ↗AP
2013-12-19Efficacy · Supplement 10 · standard — Label ↗AP
2013-12-19Efficacy · Supplement 9 · standard — Label ↗AP
2013-11-22Manufacturing (CMC) · Supplement 12 · priorityAP
2013-01-23Manufacturing (CMC) · Supplement 7 · priorityAP
2008-06-20Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2007-12-13Type 1 - New Molecular Entity · Original · priority — Review ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →