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PAROXETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SCIECURE PHARMA INC · Approved 2018-06-12

Drug application

FDA Application #

ANDA209293

Application type

Abbreviated New Drug Application (Generic)

Brand name

PAROXETINE HYDROCHLORIDE

Generic name

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Active ingredients

PAROXETINE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

SCIECURE PHARMA INC

Manufacturer

Rhodes Pharmaceuticals L.P.

First approval

2018-06-12

Source

Authoritative

Drugs@FDA application overview

Machine

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