MedPath
FDA Product

ROSUVASTATIN CALCIUM

Product approved by U.S. Food and Drug Administration (US)

Basic Information

ROSUVASTATIN CALCIUM

61919-701

Regulatory Information

61919-701

ANDA207616

C73584

August 19, 2019

USA

ROSUVASTATIN CALCIUM

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Direct_Rx

079254320

Active Ingredients

ROSUVASTATIN CALCIUM

Quantity: 20 mg in 1 1

Code: 83MVU38M7Q

Class Code: ACTIM

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)

Code: RFW2ET671P

Class Code: IACT

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

FOOD YELLOW 3 FREE ACID

Code: G2B7JWK1GG

ROSUVASTATIN

Code: 413KH5ZJ73

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