Piperacillin

ANDA 65157, held by Acs Dobfar Spa. Piperacillin Sodium.

As of Nov 15, 2026, ANDA 65157 (Piperacillin), held by Acs Dobfar Spa, was first approved by FDA on Jul 12, 2004, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2004
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 12, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
PiperacillinEQ 40GM BASE/VIAL · injectable;injection	Piperacillin Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 6, 2025	Supplement 16Labeling · Standard review	Approved	None posted
May 1, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Aug 4, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 5, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Mar 2, 2007	Supplement 2Labeling	Approved	None posted
Jul 12, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 65157
Drugs@FDA: Overview at FDA
Company: ACS Dobfar

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters