APPLICATION
ANDA090346
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-15
LATEST ACTION
2021-01-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENZPHETAMINE HYDROCHLORIDEPrescription
BENZPHETAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2021-01-06Labeling · Supplement 2 · standardAP
2015-12-15OriginalAP
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.