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FDA NDA · NDA213491

PROCYSBI

cysteamine bitartrate

Sponsor: HORIZON

APPLICATION
NDA213491
TYPE
NDA
ORIGINAL APPROVAL
2020-02-14
LATEST ACTION
2022-02-11
ROUTE
ORAL
DOSAGE FORM
GRANULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PROCYSBI · ReferencePrescription
CYSTEAMINE BITARTRATE EQ 300MG BASE/PACKET · GRANULE, DELAYED RELEASE · ORAL
PROCYSBI · ReferencePrescription
CYSTEAMINE BITARTRATE EQ 75MG BASE/PACKET · GRANULE, DELAYED RELEASE · ORAL

Approval history

2022-02-11Labeling · Supplement 2 · 901 required — Label ↗AP
2020-02-14Type 3 - New Dosage Form · Original · standard — Letter ↗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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