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FDA Approval

Rosuvastatin Calcium

CompanyTris Pharma Inc (DUNS: 947472119)

Effective Date

August 30, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Rosuvastatin(5 mg in 1 1)

Manufacturing Establishments (1)

Changzhou Pharmaceutical Factory

Labeler

Tris Pharma Inc

DUNS Number

653881060

Products (4)

Rosuvastatin Calcium

NDC Product Code

27808-155

Application Number

ANDA207408

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 28, 2023

Ingredients

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

RosuvastatinActive

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

HYPROMELLOSE 2208 (100 MPA.S)Inactive

Code: B1QE5P712KClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

Rosuvastatin Calcium

NDC Product Code

27808-156

Application Number

ANDA207408

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 28, 2023

Ingredients

RosuvastatinActive

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

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

HYPROMELLOSE 2208 (100 MPA.S)Inactive

Code: B1QE5P712KClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

Rosuvastatin Calcium

NDC Product Code

27808-157

Application Number

ANDA207408

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 28, 2023

Ingredients

RosuvastatinActive

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

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYPROMELLOSE 2208 (100 MPA.S)Inactive

Code: B1QE5P712KClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

Rosuvastatin Calcium

NDC Product Code

27808-158

Application Number

ANDA207408

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 28, 2023

Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

RosuvastatinActive

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

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

HYPROMELLOSE 2208 (100 MPA.S)Inactive

Code: B1QE5P712KClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

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