Rosuvastatin

Product NDC
71610-922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA206381
Marketing category
ANDA
Substance
ROSUVASTATIN
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
71610-922-4545 TABLET, FILM COATED in 1 BOTTLE (71610-922-45) 2025-07-08NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RosuvastatinAphena Pharma Solutions - Tennessee, LLC2025-07-09HUMAN PRESCRIPTION DRUG LABEL1