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Rosuvastatin Calcium

ANDA 207626, held by Umedica. Rosuvastatin Calcium.

  • First approved: Apr 9, 2019
  • Review: Standard
  • Supplements approved: 6
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below
DateSubmissionStatusDocuments
Apr 9, 2019Original applicationApprovedNone posted

Products

4 strengths and forms
ProductActive ingredientMarketing
Rosuvastatin CalciumEQ 5MG BASE · tablet;oralRosuvastatin CalciumRx
Rosuvastatin CalciumEQ 10MG BASE · tablet;oralRosuvastatin CalciumRx
Rosuvastatin CalciumEQ 20MG BASE · tablet;oralRosuvastatin CalciumRx
Rosuvastatin CalciumEQ 40MG BASE · tablet;oralRosuvastatin CalciumRx
All 7 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jan 14, 2025Supplement 22Labeling · Standard reviewApprovedNone posted
Jan 14, 2025Supplement 12Labeling · Standard reviewApprovedNone posted
Jan 14, 2025Supplement 10Labeling · Standard reviewApprovedNone posted
Jan 14, 2025Supplement 8Labeling · Standard reviewApprovedNone posted
Jan 14, 2025Supplement 7Labeling · Standard reviewApprovedNone posted
Jan 14, 2025Supplement 3Labeling · Standard reviewApprovedNone posted
Apr 9, 2019Original applicationApprovedNone posted

Identifiers

Application
ANDA 207626
Company
Umedica

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.