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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

Jubilant Cadista Pharmaceuticals Inc.

DUNS: 022490515

Effective Date

November 28, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Rosuvastatin(20 mg in 1 1)

Registrants1

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

Jubilant Generics Limited

DUNS Number

650801538

Manufacturing Establishments1

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

Jubilant Generics Limited

Labeler

Jubilant Cadista Pharmaceuticals Inc.

Registrant

Jubilant Generics Limited

DUNS Number

650369221

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

59746-430

Application Number

ANDA207062

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 18, 2018

Ingredients

RosuvastatinActive

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

Calcium Phosphate, Dibasic, DihydrateInactive

Code: O7TSZ97GEPClass: IACT

Anhydrous LactoseInactive

Code: 3SY5LH9PMKClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Cellulose, MicrocrystallineInactive

Code: OP1R32D61UClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

HypromellosesInactive

Code: 3NXW29V3WOClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

Fd&c Blue No. 2Inactive

Code: L06K8R7DQKClass: IACT

Crospovidone (15 Mpa.s At 5%)Inactive

Code: 68401960MKClass: IACT

Fd&c Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Fd&c Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

Rosuvastatin calcium

Product Details

NDC Product Code

59746-431

Application Number

ANDA207062

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 18, 2018

Ingredients

RosuvastatinActive

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

Calcium Phosphate, Dibasic, DihydrateInactive

Code: O7TSZ97GEPClass: IACT

Anhydrous LactoseInactive

Code: 3SY5LH9PMKClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Cellulose, MicrocrystallineInactive

Code: OP1R32D61UClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

HypromellosesInactive

Code: 3NXW29V3WOClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

Fd&c Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Fd&c Blue No. 2Inactive

Code: L06K8R7DQKClass: IACT

Fd&c Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

Crospovidone (15 Mpa.s At 5%)Inactive

Code: 68401960MKClass: IACT

Rosuvastatin calcium

Product Details

NDC Product Code

59746-428

Application Number

ANDA207062

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 18, 2018

Ingredients

RosuvastatinActive

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

Calcium Phosphate, Dibasic, DihydrateInactive

Code: O7TSZ97GEPClass: IACT

Anhydrous LactoseInactive

Code: 3SY5LH9PMKClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Cellulose, MicrocrystallineInactive

Code: OP1R32D61UClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

Crospovidone (15 Mpa.s At 5%)Inactive

Code: 68401960MKClass: IACT

Fd&c Blue No. 2Inactive

Code: L06K8R7DQKClass: IACT

HypromellosesInactive

Code: 3NXW29V3WOClass: IACT

D&c Yellow No. 10Inactive

Code: 35SW5USQ3GClass: IACT

Fd&c Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Rosuvastatin calcium

Product Details

NDC Product Code

59746-429

Application Number

ANDA207062

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

June 18, 2018

Ingredients

Calcium Phosphate, Dibasic, DihydrateInactive

Code: O7TSZ97GEPClass: IACT

Cellulose, MicrocrystallineInactive

Code: OP1R32D61UClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

HypromellosesInactive

Code: 3NXW29V3WOClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

TriacetinInactive

Code: XHX3C3X673Class: IACT

Fd&c Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Fd&c Blue No. 2Inactive

Code: L06K8R7DQKClass: IACT

Fd&c Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

RosuvastatinActive

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

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Anhydrous LactoseInactive

Code: 3SY5LH9PMKClass: IACT

Crospovidone (15 Mpa.s At 5%)Inactive

Code: 68401960MKClass: IACT

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