Rosuvastatin Calcium

Registrants (1)

Preferred Pharmaceuticals, Inc.

DUNS Number

791119022

Manufacturing Establishments (1)

Preferred Pharmaceuticals, Inc.

Labeler

Preferred Pharmaceuticals, Inc.

Registrant

Preferred Pharmaceuticals, Inc.

DUNS Number

791119022

Products (1)

NDC Product Code

68788-7612

Application Number

ANDA208898

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 20, 2023

Ingredients

RosuvastatinActive

Code: 83MVU38M7QClass: ACTIMQuantity: 20 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUYClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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Rosuvastatin Calcium

Registrants (1)

Manufacturing Establishments (1)

Products (1)

Rosuvastatin Calcium