MedPath
FDA Product

PAROXETINE HYDROCHLORIDE

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

Basic Information

PAROXETINE HYDROCHLORIDE

60505-3675

Regulatory Information

60505-3675

NDA020936

C73594

September 29, 2023

USA

These highlights do not include all the information needed to use Paroxetine HCL CR safely and effectively. See full prescribing information for . (paroxetine) extended-release tablets, for oral use Initial U.S. Approval: 1992

HUMAN PRESCRIPTION DRUG LABEL

16

Company Information

Apotex Corp

845263701

Active Ingredients

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Quantity: 37.5 mg in 1 1

Code: X2ELS050D8

Class Code: ACTIM

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

GLYCERYL DIBEHENATE

Code: R8WTH25YS2

Class Code: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER

Code: NX76LV5T8J

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

POLYETHYLENE GLYCOL 10000

Code: H57W405143

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

Active Moieties

PAROXETINE

Code: 41VRH5220H

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