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Metoprolol Succinate

ANDA 204161, held by Actavis Elizabeth. Metoprolol Succinate.

  • First approved: Nov 25, 2016
  • 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
Nov 25, 2016Original applicationApprovedNone posted

Products

4 strengths and forms
ProductActive ingredientMarketing
Metoprolol SuccinateEQ 25MG TARTRATE · tablet, extended release;oralMetoprolol SuccinateRx
Metoprolol SuccinateEQ 50MG TARTRATE · tablet, extended release;oralMetoprolol SuccinateRx
Metoprolol SuccinateEQ 100MG TARTRATE · tablet, extended release;oralMetoprolol SuccinateRx
Metoprolol SuccinateEQ 200MG TARTRATE · tablet, extended release;oralMetoprolol SuccinateRx
All 6 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Mar 12, 2025Supplement 25Labeling · Standard reviewApprovedNone posted
Dec 17, 2024Supplement 24ManufacturingApprovedNone posted
Oct 23, 2023Supplement 22Labeling · Standard reviewApprovedNone posted
Feb 27, 2023Supplement 15Labeling · Standard reviewApprovedNone posted
Feb 27, 2023Supplement 19Labeling · Standard reviewApprovedNone posted
Nov 25, 2016Original applicationApprovedNone posted

Identifiers

Application
ANDA 204161

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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