Paroxetine

Basic Information

Product Name

Paroxetine

FDA Product Code

69117-0024

Regulatory Information

NDC Product Code

69117-0024

Application Number

ANDA211248

Marketing Category

C73584

Effective Date

September 30, 2023

Territorial Authority

USA

FDA Title

PAROXETINE tablets Yiling Pharmaceutical Ltd --------------- These highlights do not include all the information needed to use PAROXETINE TABLETS safely and effectively. See full prescribing information for PAROXETINE TABLETS. PAROXETINE tablets, for oral use Initial U.S. Approval: 1992

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MALTODEXTRIN

Code: 7CVR7L4A2D

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MEDIUM-CHAIN TRIGLYCERIDES

Code: C9H2L21V7U

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Quantity: 10 mg in 1 1

Code: X2ELS050D8

Class Code: ACTIM

SODIUM STARCH GLYCOLATE TYPE A

Code: H8AV0SQX4D

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

Active Moieties

Code: 41VRH5220H

Paroxetine

Basic Information

Regulatory Information

Company Information

Active Ingredients

HYPROMELLOSES

MAGNESIUM STEARATE

MALTODEXTRIN

TITANIUM DIOXIDE

MEDIUM-CHAIN TRIGLYCERIDES

TALC

FERROSOFERRIC OXIDE

FERRIC OXIDE RED

SODIUM STARCH GLYCOLATE TYPE A

FERRIC OXIDE YELLOW

POLYDEXTROSE

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Active Moieties

PAROXETINE