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Rosuvastatin Calcium

ANDA 206465, held by Alkem Labs Ltd. Rosuvastatin Calcium.

  • First approved: Mar 21, 2017
  • Review: Standard
  • 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
Mar 21, 2017Original 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 10 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jul 31, 2026Supplement 18Labeling · Standard reviewApprovedNone posted
Jan 14, 2025Supplement 17Labeling · Standard reviewApprovedNone posted
Jan 14, 2025Supplement 16Labeling · Standard reviewApprovedNone posted
Jul 14, 2023Supplement 15Labeling · Standard reviewApprovedNone posted
Jul 14, 2023Supplement 14Labeling · Standard reviewApprovedNone posted
Jul 14, 2023Supplement 9Labeling · Standard reviewApprovedNone posted
Jul 14, 2023Supplement 8Labeling · Standard reviewApprovedNone posted
Mar 10, 2020Supplement 2Labeling · Standard reviewApprovedNone posted
Mar 10, 2020Supplement 1Labeling · Standard reviewApprovedNone posted
Mar 21, 2017Original applicationApprovedNone posted

Identifiers

Application
ANDA 206465

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.