APPLICATION
NDA216483
TYPE
NDA
ORIGINAL APPROVAL
2024-04-24
LATEST ACTION
2024-04-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PIVYA · ReferencePrescription
PIVMECILLINAM HYDROCHLORIDE EQ 185MG BASE · TABLET · ORAL
Approval history
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.