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Rosuvastatin Calcium

ANDA 79168, held by Chartwell Rx. Rosuvastatin Calcium.

  • First approved: Jul 19, 2016
  • Supplements approved: 3
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below
DateSubmissionStatusDocuments
Jul 19, 2016Original applicationApprovedLetter

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 4 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Jan 30, 2025Supplement 3Labeling · Standard reviewApprovedNone posted
Jan 30, 2025Supplement 4Labeling · Standard reviewApprovedNone posted
Jan 30, 2025Supplement 5Labeling · Standard reviewApprovedNone posted
Jul 19, 2016Original applicationApprovedLetter

Identifiers

Application
ANDA 79168

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.