Piperacillin

ANDA 65114, held by Acs Dobfar Spa. Piperacillin Sodium.

As of Nov 15, 2026, ANDA 65114 (Piperacillin), held by Acs Dobfar Spa, was first approved by FDA on Nov 14, 2003, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2003
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
Nov 14, 2003	Original application	Approved	None posted

Products

3 strengths and forms


PiperacillinEQ 2GM BASE/VIAL · injectable;injection	Piperacillin Sodium	Discontinued
PiperacillinEQ 3GM BASE/VIAL · injectable;injection	Piperacillin Sodium	Discontinued
PiperacillinEQ 4GM BASE/VIAL · injectable;injection	Piperacillin Sodium	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Nov 6, 2025	Supplement 19Labeling · Standard review	Approved	None posted
May 1, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Mar 5, 2016	Supplement 13Labeling · Standard review	Approved	None posted
Mar 2, 2007	Supplement 5Labeling	Approved	None posted
Dec 24, 2003	Supplement 1Labeling	Approved	None posted
Nov 14, 2003	Original application	Approved	None posted

Identifiers

Application: ANDA 65114
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