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FDA Approval

Rosuvastatin Calcium

CompanyProficient Rx LP (DUNS: 079196022)

Effective Date

June 1, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Rosuvastatin(20 mg in 1 1)

Manufacturing Establishments (1)

Proficient Rx LP

Labeler

Proficient Rx LP

DUNS Number

079196022

Products (4)

Rosuvastatin Calcium

NDC Product Code

63187-865

Application Number

ANDA079170

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

RosuvastatinActive

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

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Rosuvastatin Calcium

NDC Product Code

63187-864

Application Number

ANDA079170

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

RosuvastatinActive

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

Rosuvastatin Calcium

NDC Product Code

63187-872

Application Number

ANDA079170

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

RosuvastatinActive

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

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Rosuvastatin Calcium

NDC Product Code

63187-860

Application Number

ANDA079170

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 1, 2022

Ingredients

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

RosuvastatinActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

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