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FDA Approval

Rosuvastatin Calcium

CompanyNovadoz Pharmaceuticals LLC (DUNS: 081109687)

Effective Date

November 13, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Rosuvastatin(10 mg in 1 1)

Manufacturing Establishments (3)

MSN Pharmaceuticals Inc.

Labeler

Novadoz Pharmaceuticals LLC

DUNS Number

079229051

MSN LABORATORIES PRIVATE LIMITED

Labeler

Novadoz Pharmaceuticals LLC

DUNS Number

854405955

MSN LABORATORIES PRIVATE LIMITED

Labeler

Novadoz Pharmaceuticals LLC

DUNS Number

650786952

Products (5)

Rosuvastatin Calcium

NDC Product Code

72205-003

Application Number

ANDA208898

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 13, 2023

Ingredients

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

RosuvastatinActive

Code: 83MVU38M7QClass: ACTIMQuantity: 10 mg in 1 1

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUYClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Rosuvastatin Calcium

NDC Product Code

72205-004

Application Number

ANDA208898

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 13, 2023

Ingredients

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

RosuvastatinActive

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

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUYClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Rosuvastatin Calcium

NDC Product Code

72205-027

Application Number

ANDA208898

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 13, 2023

Ingredients

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

RosuvastatinActive

Code: 83MVU38M7QClass: ACTIMQuantity: 5 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUYClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Rosuvastatin Calcium

NDC Product Code

72205-002

Application Number

ANDA208898

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 13, 2023

Ingredients

TRIACETINInactive

Code: XHX3C3X673Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

RosuvastatinActive

Code: 83MVU38M7QClass: ACTIMQuantity: 5 mg in 1 1

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUYClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Rosuvastatin Calcium

NDC Product Code

72205-005

Application Number

ANDA208898

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 13, 2023

Ingredients

RosuvastatinActive

Code: 83MVU38M7QClass: ACTIMQuantity: 40 mg in 1 1

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUYClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

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