← FDA DRUG APPROVALS

FDA NDA · NDA022402

CODEINE SULFATE

Sponsor: HIKMA

APPLICATION
NDA022402
TYPE
NDA
ORIGINAL APPROVAL
2009-07-16
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CODEINE SULFATE · ReferencePrescription
CODEINE SULFATE 60MG · TABLET · ORAL
CODEINE SULFATE · ReferencePrescription
CODEINE SULFATE 15MG · TABLET · ORAL
CODEINE SULFATE · ReferencePrescription
CODEINE SULFATE 30MG · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 19 — Letter ↗AP
2025-12-22Labeling · Supplement 17 · standard — Letter ↗AP
2024-10-31REMS · Supplement 16 — Letter ↗AP
2023-12-15Labeling · Supplement 15 · standard — Label ↗AP
2021-03-04Labeling · Supplement 14 · standard — Letter ↗AP
2019-10-07Labeling · Supplement 12 · standard — Letter ↗AP
2018-09-18REMS · Supplement 10 — Label ↗AP
2018-09-18Labeling · Supplement 11 · standard — Label ↗AP
2017-08-29Labeling · Supplement 9 · standard — Label ↗AP
2016-12-16Labeling · Supplement 8 · standard — Label ↗AP
2013-06-17Manufacturing (CMC) · Supplement 5 · standardAP
2013-05-09Labeling · Supplement 6 · 901 required — Letter ↗AP
2012-04-17Labeling · Supplement 3 · standard — Label ↗AP
2009-07-16Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →