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FDA Approval

Rosuvastatin Calcium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Rosuvastatin(10 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Rosuvastatin Calcium

Product Details

NDC Product Code
50090-4738
Application Number
ANDA079172
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 21, 2022
Code: 83MVU38M7QClass: ACTIMQuantity: 10 mg in 1 1
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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