MedPath
FDA Product

Amlodipine and atorvastatin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amlodipine and atorvastatin

68382-431

Regulatory Information

68382-431

ANDA207762

C73584

October 31, 2020

USA

These highlights do not include all the information needed to use AMLODIPINE AND ATORVASTATIN TABLETS safely and effectively. See full prescribing information for AMLODIPINE AND ATORVASTATIN TABLETS. AMLODIPINE AND ATORVASTATIN tablets, for oral useInitial U.S. Approval: 2004

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

156861945

Active Ingredients

AMLODIPINE BESYLATE

Quantity: 10 mg in 1 1

Code: 864V2Q084H

Class Code: ACTIM

CALCIUM CARBONATE

Code: H0G9379FGK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ATORVASTATIN CALCIUM TRIHYDRATE

Quantity: 10 mg in 1 1

Code: 48A5M73Z4Q

Class Code: ACTIM

Active Moieties

AMLODIPINE

Code: 1J444QC288

ATORVASTATIN

Code: A0JWA85V8F

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