MedPath
FDA Approval

Rosuvastatin Calcium

January 10, 2024

HUMAN PRESCRIPTION DRUG LABEL

Rosuvastatin(10 mg in 1 1)

Products (2)

Rosuvastatin Calcium

42677-302

ANDA207375

ANDA (C73584)

ORAL

January 10, 2024

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Code: 83MVU38M7QClass: ACTIMQuantity: 10 mg in 1 1
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT

Rosuvastatin Calcium

42677-301

ANDA207375

ANDA (C73584)

ORAL

January 10, 2024

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Code: 83MVU38M7QClass: ACTIMQuantity: 5 mg in 1 1
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUYClass: IACT
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