← FDA DRUG APPROVALS

FDA ANDA · ANDA065157

PIPERACILLIN

Sponsor: ISTITUTO BIO ITA SPA

APPLICATION
ANDA065157
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-12
LATEST ACTION
2025-11-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PIPERACILLINPrescription
PIPERACILLIN SODIUM EQ 40GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-11-06Labeling · Supplement 16 · standardAP
2024-05-01Labeling · Supplement 15 · standardAP
2020-08-04Labeling · Supplement 10 · standardAP
2016-03-05Labeling · Supplement 9 · standardAP
2007-03-02Labeling · Supplement 2AP
2004-07-12OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

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

Read a past issue →