MedPath
FDA Product

Paroxetine

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

Basic Information

Paroxetine

65841-097

Regulatory Information

65841-097

ANDA077584

C73584

October 31, 2022

USA

Paroxetine Tablets, USP

HUMAN PRESCRIPTION DRUG LABEL

11

Company Information

918596198

Active Ingredients

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

PAROXETINE HYDROCHLORIDE ANHYDROUS

Quantity: 10 mg in 1 1

Code: 3I3T11UD2S

Class Code: ACTIM

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

PAROXETINE

Code: 41VRH5220H

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