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FDA NDA · NDA207768

TUZISTRA XR

Sponsor: TRIS PHARMA INC

APPLICATION
NDA207768
TYPE
NDA
ORIGINAL APPROVAL
2015-04-30
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TUZISTRA XR · ReferenceDiscontinued
CHLORPHENIRAMINE POLISTIREX EQ 2.8MG BASE/5ML, CODEINE POLISTIREX EQ 14.7MG BASE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2025-12-22Labeling · Supplement 14 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 13 · standard — Label ↗AP
2018-06-28Labeling · Supplement 7 · standard — Label ↗AP
2017-08-29Labeling · Supplement 6 · standard — Label ↗AP
2017-02-17Manufacturing (CMC) · Supplement 3AP
2017-01-13Labeling · Supplement 4 · standard — Label ↗AP
2016-02-19Manufacturing (CMC) · Supplement 2 · standardAP
2015-12-04Manufacturing (CMC) · Supplement 1 · standardAP
2015-04-30Type 3 - New Dosage Form · Original · standard — Summary Review ↗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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