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FDA NDA · NDA205065

KUVAN

sapropterin dihydrochloride

Sponsor: BIOMARIN PHARM

APPLICATION
NDA205065
TYPE
NDA
ORIGINAL APPROVAL
2013-12-19
LATEST ACTION
2024-08-26
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

KUVAN · ReferencePrescription
SAPROPTERIN DIHYDROCHLORIDE 100MG/PACKET · FOR SOLUTION · ORAL
KUVAN · ReferencePrescription
SAPROPTERIN DIHYDROCHLORIDE 500MG/PACKET · FOR SOLUTION · ORAL

Approval history

2024-08-26Labeling · Supplement 8 · standard — Letter ↗AP
2020-03-16Labeling · Supplement 6 · standard — Label ↗AP
2019-12-13Labeling · Supplement 7 · standard — Letter ↗AP
2019-05-02Labeling · Supplement 5 · standard — Label ↗AP
2016-08-09Labeling · Supplement 2 · standard — Label ↗AP
2015-10-28Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2013-12-19Type 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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