← FDA DRUG APPROVALS

FDA NDA · NDA203389

PROCYSBI

cysteamine bitartrate

Sponsor: HORIZON

APPLICATION
NDA203389
TYPE
NDA
ORIGINAL APPROVAL
2013-04-30
LATEST ACTION
2022-02-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

PROCYSBI · ReferencePrescription
CYSTEAMINE BITARTRATE EQ 25MG BASE · CAPSULE, DELAYED RELEASE · ORAL
PROCYSBI · ReferencePrescription
CYSTEAMINE BITARTRATE EQ 75MG BASE · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2022-02-11Labeling · Supplement 27 · 901 required — Label ↗AP
2020-06-24Labeling · Supplement 23 · standard — Label ↗AP
2019-05-31Labeling · Supplement 22 · standard — Label ↗AP
2017-12-22Efficacy · Supplement 20 · priority — Letter ↗AP
2017-11-21Labeling · Supplement 18 · standardAP
2017-09-24Labeling · Supplement 17 · standard — Label ↗AP
2016-05-13Manufacturing (CMC) · Supplement 15 · standardAP
2016-03-21Manufacturing (CMC) · Supplement 16 · standardAP
2016-03-10Manufacturing (CMC) · Supplement 14 · standardAP
2015-09-09Manufacturing (CMC) · Supplement 13 · standardAP
2015-08-14Efficacy · Supplement 10 · standard — Label ↗AP
2015-04-08Manufacturing (CMC) · Supplement 12 · standardAP
2014-12-02Manufacturing (CMC) · Supplement 11 · standardAP
2014-04-21Manufacturing (CMC) · Supplement 5 · standardAP
2014-01-30Manufacturing (CMC) · Supplement 4 · standardAP
2013-10-31Manufacturing (CMC) · Supplement 3 · standardAP
2013-10-18Manufacturing (CMC) · Supplement 2 · standardAP
2013-10-08Manufacturing (CMC) · Supplement 1 · standardAP
2013-04-30Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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