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FDA NDA · NDA205739

VELTASSA

patiromer

Sponsor: VIFOR PHARMA

APPLICATION
NDA205739
TYPE
NDA
ORIGINAL APPROVAL
2015-10-21
LATEST ACTION
2023-10-02
ROUTE
ORAL
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued, Prescription

Products

VELTASSA · ReferenceDiscontinued
PATIROMER SORBITEX CALCIUM EQ 25.2GM BASE/PACKET · POWDER · ORAL
VELTASSA · ReferencePrescription
PATIROMER SORBITEX CALCIUM EQ 8.4GM BASE/PACKET · POWDER · ORAL
VELTASSA · ReferencePrescription
PATIROMER SORBITEX CALCIUM EQ 1GM BASE/PACKET · POWDER · ORAL
VELTASSA · ReferencePrescription
PATIROMER SORBITEX CALCIUM EQ 16.8GM BASE/PACKET · POWDER · ORAL

Approval history

2023-10-02Efficacy · Supplement 38 · standard — Label ↗AP
2023-03-27Labeling · Supplement 37 · standard — Letter ↗AP
2021-12-22Labeling · Supplement 35 · standard — Letter ↗AP
2021-05-14Labeling · Supplement 31 · standard — Letter ↗AP
2018-05-02Efficacy · Supplement 16 · standard — Letter ↗AP
2016-12-01Manufacturing (CMC) · Supplement 10 · standardAP
2016-11-25Labeling · Supplement 9 · standard — Letter ↗AP
2016-06-16Manufacturing (CMC) · Supplement 5 · standardAP
2016-05-20Labeling · Supplement 1 · standard — Label ↗AP
2016-05-10Manufacturing (CMC) · Supplement 4 · standardAP
2015-10-21Type 1 - New Molecular Entity · 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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