MedPath
FDA Approval

Rosuvastatin Calcium

April 30, 2019

HUMAN PRESCRIPTION DRUG LABEL

Rosuvastatin(10 mg in 1 1)

Manufacturing Establishments (1)

A-S Medication Solutions

A-S Medication Solutions

830016429

Products (1)

Rosuvastatin Calcium

50090-4039

ANDA201619

ANDA (C73584)

ORAL

January 1, 2019

Code: 83MVU38M7QClass: ACTIMQuantity: 10 mg in 1 1
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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