APPLICATION
ANDA065173
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-14
LATEST ACTION
2015-10-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PAROMOMYCIN SULFATEPrescription
PAROMOMYCIN SULFATE EQ 250MG BASE · CAPSULE · ORAL
Approval history
2015-10-28Manufacturing (CMC) · Supplement 1 · unknownAP
2007-12-14OriginalAP
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.