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Rosuvastatin Calcium

ANDA 207453, held by Cadila Pharms Ltd. Rosuvastatin Calcium.

  • First approved: Nov 23, 2016
  • Review: Standard
  • 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 23, 2016Original 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 6 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Sep 27, 2024Supplement 5Labeling · Standard reviewApprovedNone posted
Sep 27, 2024Supplement 6Labeling · Standard reviewApprovedNone posted
Mar 10, 2020Supplement 1Labeling · Standard reviewApprovedNone posted
Mar 10, 2020Supplement 3Labeling · Standard reviewApprovedNone posted
Mar 10, 2020Supplement 4Labeling · Standard reviewApprovedNone posted
Nov 23, 2016Original applicationApprovedNone posted

Identifiers

Application
ANDA 207453

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.