TheraRadar
Data updated: Nov 8, 2026

PIPERACILLIN (piperacillin sodium) · ACS DOBFAR SPA

Generic · see PIPRACIL
Infectious Disease Approved 2003-11-14
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Discontinued
First Approved
2003-11-14
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

ACS DOBFAR SPA
Active Ingredient: PIPERACILLIN SODIUM

PIPERACILLIN Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2003 to 2025
Nov 2025 SUPPL
Label · Labeling
May 2024 SUPPL
Label · Labeling
Aug 2020 SUPPL
Label · Labeling

What PIPERACILLIN Treats

2 FDA approvals

Originally approved for its first indication in 2003 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT02493764 RESTORE-IMI 2 results posted 7655A-014 2015-000246-34, 163240 Ph 3 completed Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014)
NCT00894439 3219K1-1002 Ph 1 completed Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PIPERACILLIN FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

Looking for the branded version?

PIPRACIL

Full clinical data, patents, trials, and competitive landscape for piperacillin sodium.

See PIPRACIL

Data Sources

FDA Approval: ANDA065157 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.