← FDA DRUG APPROVALS

FDA NDA · NDA022076

LOCOID

Sponsor: BAUSCH

APPLICATION
NDA022076
TYPE
NDA
ORIGINAL APPROVAL
2007-05-18
LATEST ACTION
2023-10-18
ROUTE
TOPICAL
DOSAGE FORM
LOTION
MARKETING STATUS
Discontinued

Products

LOCOID · ReferenceDiscontinued
HYDROCORTISONE BUTYRATE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LOTION · TOPICAL

Approval history

2023-10-18Labeling · Supplement 6 · standard — Letter ↗AP
2014-10-30Labeling · Supplement 5 · standard — Label ↗AP
2013-11-19Manufacturing (CMC) · Supplement 4 · standardAP
2007-05-18Type 3 - New Dosage Form · Original · standard — 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 →