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FDA Approval

Rosuvastatin Calcium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Major Pharmaceuticals

DUNS: 191427277

Effective Date

February 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Rosuvastatin(40 mg in 1 1)

Products4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Rosuvastatin Calcium

Product Details

NDC Product Code

0904-6781

Application Number

ANDA201619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 27, 2023

Ingredients

RosuvastatinActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

Rosuvastatin Calcium

Product Details

NDC Product Code

0904-6779

Application Number

ANDA201619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 27, 2023

Ingredients

RosuvastatinActive

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

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Rosuvastatin Calcium

Product Details

NDC Product Code

0904-6778

Application Number

ANDA201619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 27, 2023

Ingredients

RosuvastatinActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Rosuvastatin Calcium

Product Details

NDC Product Code

0904-6780

Application Number

ANDA201619

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 27, 2023

Ingredients

RosuvastatinActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONE (120 .MU.M)Inactive

Code: 68401960MKClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

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