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Morphine Sulfate

ANDA 210610, held by Upsher Smith Labs. Morphine Sulfate.

  • First approved: Jul 22, 2019
  • Review: Standard
  • Supplements approved: 2
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below
DateSubmissionStatusDocuments
Jul 22, 2019Original applicationApprovedREMSLetter

Products

2 strengths and forms
ProductActive ingredientMarketing
Morphine Sulfate15MG · tablet;oralMorphine SulfateRx
Morphine Sulfate30MG · tablet;oralMorphine SulfateRx
All 3 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jun 18, 2026Supplement 13REMSApprovedNone posted
Oct 31, 2024Supplement 10REMSApprovedNone posted
Jul 22, 2019Original applicationApprovedREMSLetter

Identifiers

Application
ANDA 210610

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.