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FDA NDA · NDA202245

CODEINE SULFATE

Sponsor: HIKMA

APPLICATION
NDA202245
TYPE
NDA
ORIGINAL APPROVAL
2011-06-30
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CODEINE SULFATEDiscontinued
CODEINE SULFATE 30MG/5ML · SOLUTION · ORAL

Approval history

2026-06-18REMS · Supplement 13 — Letter ↗AP
2025-12-22Labeling · Supplement 12 · standard — Letter ↗AP
2024-10-31REMS · Supplement 11 — Letter ↗AP
2023-12-15Labeling · Supplement 10 · standard — Label ↗AP
2021-03-04Labeling · Supplement 9 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 8 · standard — Letter ↗AP
2018-09-18Labeling · Supplement 7 · standard — Label ↗AP
2018-09-18REMS · Supplement 6 — Label ↗AP
2017-08-29Labeling · Supplement 5 · standard — Label ↗AP
2016-12-16Labeling · Supplement 4 · standard — Label ↗AP
2013-05-09Labeling · Supplement 2 · 901 required — Label ↗AP
2012-04-17Labeling · Supplement 1 · standard — Label ↗AP
2011-06-30Type 5 - New Formulation or New Manufacturer · Original · standard — REMS ↗AP
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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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