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Piperacillin And Tazobactam

ANDA 203719, held by Fresenius Kabi. Piperacillin Sodium; Tazobactam Sodium.

  • First approved: May 18, 2018
  • Supplements approved: 5
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below
DateSubmissionStatusDocuments
May 18, 2018Original applicationApprovedNone posted

Products

3 strengths and forms
ProductActive ingredientMarketing
Piperacillin And TazobactamEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL · injectable;injectionPiperacillin Sodium; Tazobactam SodiumRx
Piperacillin And TazobactamEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL · injectable;injectionPiperacillin Sodium; Tazobactam SodiumRx
Piperacillin And TazobactamEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL · injectable;injectionPiperacillin Sodium; Tazobactam SodiumRx
All 6 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Dec 3, 2024Supplement 14Labeling · Standard reviewApprovedNone posted
May 1, 2024Supplement 12Labeling · Standard reviewApprovedNone posted
Apr 5, 2024Supplement 9Labeling · Standard reviewApprovedNone posted
Apr 5, 2024Supplement 10Labeling · Standard reviewApprovedNone posted
Feb 18, 2021Supplement 3Labeling · Standard reviewApprovedNone posted
May 18, 2018Original applicationApprovedNone posted

Identifiers

Application
ANDA 203719

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

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