APPLICATION
ANDA075274
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-26
LATEST ACTION
2004-04-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NALTREXONE HYDROCHLORIDEPrescription
NALTREXONE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2004-04-21Labeling · Supplement 5AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.