MedPath
FDA Product

Fluphenazine Hydrochloride

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

Basic Information

Fluphenazine Hydrochloride

60505-4768

Regulatory Information

60505-4768

ANDA216649

C73584

April 14, 2023

USA

Fluphenazine Hydrochloride Tablets, USP

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

Apotex Corp.

845263701

Active Ingredients

FLUPHENAZINE HYDROCHLORIDE

Quantity: 1 mg in 1 1

Code: ZOU145W1XL

Class Code: ACTIB

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

HYPROMELLOSE 2910 (4000 MPA.S)

Code: RN3152OP35

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 3350

Code: G2M7P15E5P

Class Code: IACT

Active Moieties

Fluphenazine

Code: S79426A41Z

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