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Rosuvastatin Calcium

ANDA 207408, held by Changzhou Pharm. Rosuvastatin Calcium.

  • First approved: Oct 31, 2016
  • Review: Standard
  • Supplements approved: 7
  • Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below
DateSubmissionStatusDocuments
Oct 31, 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 8 submissions, including labeling and manufacturing supplements
DateSubmissionStatusDocuments
Nov 25, 2024Supplement 26Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 15Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 17Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 22Labeling · Standard reviewApprovedNone posted
Nov 22, 2023Supplement 24Labeling · Standard reviewApprovedNone posted
Apr 3, 2019Supplement 2Labeling · Standard reviewApprovedNone posted
Apr 3, 2019Supplement 8Labeling · Standard reviewApprovedNone posted
Oct 31, 2016Original applicationApprovedNone posted

Identifiers

Application
ANDA 207408

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

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