FDA.report

Rosuvastatin Calcium

Product NDC
47335-584
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA079169
Marketing category
ANDA
Substance
ROSUVASTATIN CALCIUM
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
47335-584-181000 TABLET, FILM COATED in 1 BOTTLE (47335-584-18) 2023-06-23NoHistorical
47335-584-8190 TABLET, FILM COATED in 1 BOTTLE (47335-584-81) 2021-03-01NoHistorical
47335-584-8330 TABLET, FILM COATED in 1 BOTTLE (47335-584-83) 2023-06-23NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2024-08-08Human Prescription Drug Label16