MedPath
FDA Product

Pitavastatin

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

Basic Information

Pitavastatin

0480-3631

Regulatory Information

0480-3631

ANDA205932

C73584

December 10, 2023

USA

These highlights do not include all the information needed to use PITAVASTATIN TABLETS safely and effectively. See full prescribing information for PITAVASTATIN TABLETS. Pitavastatin tablets, film coated for oral use. Initial U.S. Approval: 2009

HUMAN PRESCRIPTION DRUG LABEL

24

Company Information

022629579

Active Ingredients

PITAVASTATIN CALCIUM

Quantity: 1.045 mg in 1 1

Code: IYD54XEG3W

Class Code: ACTIM

Inactive Ingredients

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM OXIDE

Code: 3A3U0GI71G

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

Active Moieties

PITAVASTATIN

Code: M5681Q5F9P

© Copyright 2025. All Rights Reserved by MedPath