MedPath
FDA Product

Paroxetine

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

Basic Information

Paroxetine

53808-0655

Regulatory Information

53808-0655

ANDA078902

C73584

August 12, 2010

USA

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

829348114

Active Ingredients

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

HYDROXYPROPYL CELLULOSE

Code: RFW2ET671P

Class Code: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

HYPROMELLOSE

Code: 3NXW29V3WO

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL

Code: 3WJQ0SDW1A

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Quantity: 40 mg in 1 1

Code: X2ELS050D8

Class Code: ACTIM

POLYDEXTROSE

Code: VH2XOU12IE

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

PAROXETINE

Code: 41VRH5220H

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