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PAROXETINE HYDROCHLORIDE

ANDA

PAROXETINE HYDROCHLORIDE | A077873 | AUROBINDO PHARMA USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PAXIL CR(TE code: AB)

API Supply Chain13 active DMFs12 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

GLAXOSMITHKLINEPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 150392000

ZYDUS LIFESCIENCES LTDPAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE)

DMF 166802003

MEDICHEM SAPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 180522005

APITORIA PHARMA PRIVATE LTDPAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP

DMF 191522006

SUN PHARMACEUTICAL INDUSTRIES LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 191782006

ORCHID PHARMA LTDPAROXETINE HYDROCHLORIDE

DMF 197512006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 199222006

WANBURY LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 202482006

APOTEX INCPAROXETINE HYDROCHLORIDE ANHYDROUS USP

DMF 214402008

SIGNA SA DE CVPAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 287632014

MATRIX PHARMACORP PRIVATE LTDPAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE)

DMF 387932023

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDPAROXETINE HYDROCHLORIDE

DMF 403252024

ZHEJIANG HAISEN PHARMACEUTICAL CO LTDPAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 433452025

APOTEX PHARMACHEM INCInactivePAROXETINE HYDROCHLORIDE (ANHYDROUS)

DMF 127701997

SUMITOMO CHEMICAL CO LTDInactivePAROXETINE HYDROCHLORIDE ANHYDRATE

DMF 138881998

ASAHI GLASS CO LTDInactivePAROXETINE HYDROCHLORIDE AMORPHOUS

DMF 144321999

GLAXOSMITHKLINEInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 144751999

AESICA PHARMACEUTICALS LTDInactivePAROXETINE HYDROCHLORIDE

DMF 149132000

ITF CHEMICAL LTDAInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 162472002

TEVA PHARMACEUTICAL INDUSTRIES LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 164162003

RECORDATI ESPANA SLInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 172932004

TAIZHOU HIGHSUN PHARMACEUTICAL CO LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE USP

DMF 198032006

DR REDDYS LABORATORIES LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 199702006

IPCA LABORATORIES LTDInactivePAROXETINE HYDROCHLORIDE

DMF 210072008

AESICA PHARMACEUTICALS LTDInactivePAROXETINE HYDROCHLORIDE HEMIHYDRATE

DMF 249602011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 5, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 12.5MG BASE

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 29, 2007

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Jun 29, 2007