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Hepzato

NDA 201848, held by Delcath Systems Inc. Melphalan Hydrochloride.

  • First approved: Aug 14, 2023
  • Review: Standard
  • Supplements approved: 9
  • Complete response letters: 1

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below
DateSubmissionStatusDocuments
Aug 14, 2023Original applicationNew combination · Standard reviewApprovedReviewREMSLabelLetter

Complete Response Letters

FDA's published letters for this application; each opens the letter
LetterProductNow
Sep 12, 2013Melblez KitApproved

Products

1 strengths and forms
ProductActive ingredientMarketing
HepzatoEQ 50MG BASE/VIAL · powder;intra-arterialMelphalan HydrochlorideRxReference drug
All 10 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Aug 12, 2026Supplement 18REMSApprovedLetter
Jun 29, 2026Supplement 19Labeling · Standard reviewApprovedLetter
May 28, 2026Supplement 16Labeling · Standard reviewApprovedLabelLetter
Sep 4, 2025Supplement 15REMSApprovedLetter
Jul 30, 2025Supplement 10Labeling · Standard reviewApprovedNone posted
Oct 1, 2024Supplement 7REMSApprovedLetter
Jul 10, 2024Supplement 5ManufacturingApprovedLetterLabel
May 22, 2024Supplement 3Labeling · Standard reviewApprovedLabelLetter
Jan 22, 2024Supplement 4REMSApprovedLetter
Aug 14, 2023Original applicationNew combination · Standard reviewApprovedReviewREMSLabelLetter

Identifiers

Application
NDA 201848

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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