MedPath
FDA Approval

Rosuvastatin

August 2, 2023

Human Prescription Drug Label

Rosuvastatin(20 mg in 1 1)

Manufacturing Establishments (1)

Quality Care Products, LLC

Quality Care Products, LLC

831276758

Products (2)

Rosuvastatin

55700-575

ANDA207616

ANDA (C73584)

ORAL

August 15, 2022

Code: 83MVU38M7QClass: ACTIMQuantity: 20 mg in 1 1
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT

Rosuvastatin

55700-574

ANDA207616

ANDA (C73584)

ORAL

August 15, 2022

CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
Code: 83MVU38M7QClass: ACTIMQuantity: 10 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
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