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Rosuvastatin Calcium

ANDA 79167, held by Watson Labs Inc. Rosuvastatin Calcium.

  • First approved: Apr 29, 2016
  • 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
Apr 29, 2016Original applicationApprovedLetterLabel

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
Nov 26, 2024Supplement 6Labeling · Standard reviewApprovedNone posted
Nov 26, 2024Supplement 7Labeling · Standard reviewApprovedNone posted
Nov 26, 2024Supplement 8Labeling · Standard reviewApprovedNone posted
Nov 26, 2024Supplement 9Labeling · Standard reviewApprovedNone posted
Sep 6, 2016Supplement 4Labeling · Standard reviewApprovedNone posted
Apr 29, 2016Original applicationApprovedLetterLabel

Identifiers

Application
ANDA 79167

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.