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FDA NDA · NDA206323

TUXARIN

codeine phosphate and chlorpheniramine maleate

Sponsor: MAINPOINTE

APPLICATION
NDA206323
TYPE
NDA
ORIGINAL APPROVAL
2015-06-22
LATEST ACTION
2026-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

TUXARIN ERPrescription
CHLORPHENIRAMINE MALEATE 8MG, CODEINE PHOSPHATE 54.3MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-07-10Labeling · Supplement 9 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 8 · standard — Letter ↗AP
2018-06-28Labeling · Supplement 6 · standard — Label ↗AP
2017-08-29Labeling · Supplement 5 · standard — Label ↗AP
2017-01-13Labeling · Supplement 4 · standard — Label ↗AP
2016-08-25Labeling · Supplement 1 · standard — Label ↗AP
2015-06-22Type 4 - New Combination · 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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