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Rifampin

ANDA 91181, held by Fresenius Kabi USA. Rifampin.

  • First approved: Aug 21, 2014
  • Supplements approved: 9
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below
DateSubmissionStatusDocuments
Aug 21, 2014Original applicationApprovedNone posted

Products

1 strengths and forms
ProductActive ingredientMarketing
Rifampin600MG/VIAL · injectable;injectionRifampinRx
All 10 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Sep 29, 2026Supplement 14Labeling · Standard reviewApprovedNone posted
Jul 25, 2025Supplement 13Labeling · Standard reviewApprovedNone posted
Jun 12, 2024Supplement 3Labeling · Standard reviewApprovedNone posted
Jun 12, 2024Supplement 7Labeling · Standard reviewApprovedNone posted
Jun 12, 2024Supplement 8Labeling · Standard reviewApprovedNone posted
Jun 12, 2024Supplement 9Labeling · Standard reviewApprovedNone posted
Jun 12, 2024Supplement 10Labeling · Standard reviewApprovedNone posted
Jun 12, 2024Supplement 11Labeling · Standard reviewApprovedNone posted
Jun 12, 2024Supplement 12Labeling · Standard reviewApprovedNone posted
Aug 21, 2014Original applicationApprovedNone posted

Identifiers

Application
ANDA 91181

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

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.