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FDA NDA · NDA020769

HYDROCORTISONE BUTYRATE

Sponsor: PRECISION DERMAT

APPLICATION
NDA020769
TYPE
NDA
ORIGINAL APPROVAL
1997-09-08
LATEST ACTION
2024-10-03
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

LOCOID LIPOCREAM · ReferencePrescription
HYDROCORTISONE BUTYRATE 0.1% · CREAM · TOPICAL

Approval history

2024-10-03Labeling · Supplement 15 · standard — Letter ↗AP
2014-11-20Labeling · Supplement 14 · standard — Label ↗AP
2009-10-19Efficacy · Supplement 11 · standard — Label ↗AP
2009-09-04Manufacturing (CMC) · Supplement 12AP
2006-04-21Manufacturing (CMC) · Supplement 9 — Letter ↗AP
2004-08-23Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
1998-03-12Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-08Type 3 - New Dosage Form · 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.

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