MedPath
FDA Approval

Rosuvastatin Calcium

November 1, 2019

HUMAN PRESCRIPTION DRUG LABEL

Rosuvastatin(40 mg in 1 1)

Manufacturing Establishments (1)

Proficient Rx LP

Proficient Rx LP

079196022

Products (1)

Rosuvastatin Calcium

63187-869

ANDA079166

ANDA (C73584)

ORAL

December 1, 2018

TALCInactive
Code: 7SEV7J4R1UClass: IACT
Code: 83MVU38M7QClass: ACTIMQuantity: 40 mg in 1 1
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95Class: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UIClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
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