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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

Zhejiang Yongtai Pharmaceutical Co., Ltd.

DUNS: 544302778

Effective Date

September 11, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Rosuvastatin(40 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Zhejiang Yongtai Pharmaceutical Co., Ltd.

DUNS Number

544302778

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Zhejiang Yongtai Pharmaceutical Co., Ltd.

Labeler

Zhejiang Yongtai Pharmaceutical Co., Ltd.

Registrant

Zhejiang Yongtai Pharmaceutical Co., Ltd.

DUNS Number

544302778

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

69434-008

Application Number

ANDA212059

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 11, 2020

Ingredients

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

RosuvastatinActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Anhydrous Dibasic Calcium PhosphateInactive

Code: L11K75P92JClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

Rosuvastatin Calcium

Product Details

NDC Product Code

69434-007

Application Number

ANDA212059

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 11, 2020

Ingredients

RosuvastatinActive

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

Anhydrous Dibasic Calcium PhosphateInactive

Code: L11K75P92JClass: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Rosuvastatin Calcium

Product Details

NDC Product Code

69434-005

Application Number

ANDA212059

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 11, 2020

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Anhydrous Dibasic Calcium PhosphateInactive

Code: L11K75P92JClass: IACT

CrospovidoneInactive

Code: 2S7830E561Class: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

RosuvastatinActive

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Rosuvastatin Calcium

Product Details

NDC Product Code

69434-006

Application Number

ANDA212059

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 11, 2020

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

RosuvastatinActive

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

Anhydrous Dibasic Calcium PhosphateInactive

Code: L11K75P92JClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6Class: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

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