FDA ANDA · ANDA065162

AMOXICILLIN AND CLAVULANATE POTASSIUM

Sponsor: TEVA

APPLICATION

ANDA065162

TYPE

ANDA

ORIGINAL APPROVAL

2004-03-12

LATEST ACTION

2024-05-01

ROUTE

ORAL

DOSAGE FORM

FOR SUSPENSION

MARKETING STATUS

Prescription

Products

AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription

AMOXICILLIN 600MG/5ML, CLAVULANATE POTASSIUM EQ 42.9MG BASE/5ML · FOR SUSPENSION · ORAL

2024-05-01Labeling · Supplement 40 · standardAP

2024-04-26Labeling · Supplement 29 · standardAP

2024-04-26Labeling · Supplement 36 · standardAP

2024-04-26Labeling · Supplement 32 · standardAP

2015-02-17Labeling · Supplement 8AP

2013-04-26Labeling · Supplement 23AP

2009-03-05Labeling · Supplement 21 — Letter ↗AP

2006-09-08Labeling · Supplement 16AP

2005-10-17Labeling · Supplement 13AP

2004-03-12Original — Review ↗AP

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

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.