← FDA DRUG APPROVALS

FDA ANDA · ANDA202090

SODIUM OXYBATE

Sponsor: HIKMA

APPLICATION
ANDA202090
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-17
LATEST ACTION
2025-07-08
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

SODIUM OXYBATEDiscontinued
SODIUM OXYBATE 0.5GM/ML · SOLUTION · ORAL

Approval history

2025-07-08REMS · Supplement 10 — Letter ↗AP
2023-12-08REMS · Supplement 6AP
2022-01-03Labeling · Supplement 4 · standardAP
2022-01-03Labeling · Supplement 2 · standardAP
2022-01-03Labeling · Supplement 5 · standardAP
2022-01-03Labeling · Supplement 3 · standardAP
2022-01-03Labeling · Supplement 1 · standardAP
2017-01-17Not Applicable · Original — Letter ↗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 →