APPLICATION
ANDA216554
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-31
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMPICILLIN TRIHYDRATEPrescription
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE · CAPSULE · ORAL
AMPICILLIN TRIHYDRATEPrescription
AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 1 · standardAP
2023-10-31UNKNOWN · Original · standardAP
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.