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SERTRALINE HYDROCHLORIDE

ANDA

SERTRALINE HYDROCHLORIDE | A075719 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA

3 strengths0 unique patents0 unique exclusivities

API Supply Chain18 active DMFs10 inactive

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

DR REDDYS LABORATORIES LTDSERTRALINE HYDROCHLORIDE (FORM II)

DMF 160092002

MATRIX PHARMACORP PRIVATE LTDSERTRALINE HYDROCHLORIDE USP (FORM II)

DMF 173252004

APITORIA PHARMA PRIVATE LTDSERTRALINE HYDROCHLORIDE USP (CRYSTALLINE POLYMORPH FORM II)

DMF 174352004

LUPIN LTDSERTRALINE HYDROCHLORIDE USP

DMF 182392005

TORRENT PHARMACEUTICALS LTDSERTRALINE HYDROCHLORIDE DRUG SUBSTANCE

DMF 183112005

WANBURY LTDSERTRALINE HYDROCHLORIDE

DMF 190352005

WANBURY LTDSERTRALINE HYDROCHLORIDE FORM I

DMF 199312006

APITORIA PHARMA PRIVATE LTDSERTRALINE HYDROCHLORIDE USP CRYSTALLINE POLYMORPH FORM I

DMF 226522009

CHEMECA DRUGS PRIVATE LTDSERTRALINE HYDROCHLORIDE USP

DMF 335352019

AMOLI ORGANICS PRIVATE LTDSERTRALINE HYDROCHLORIDE USP

DMF 362582021

LEE PHARMA LTDSERTRALINE HYDROCHLORIDE FORM-II

DMF 377332023

SYMED LABS LTDSERTRALINE HYDROCHLORIDE (FORM-I) USP

DMF 381632023

EXEMED PHARMACEUTICALSSERTRALINE HYDROCHLORIDE USP

DMF 394322024

VIYASH LIFE SCIENCES PRIVATE LTDSERTRALINE HYDROCHLORIDE (FORM-II)

DMF 397172024

RL FINE CHEM PVT LTDSERTRALINE HYDROCHLORIDE FORM I

DMF 405282024

EXEMED PHARMACEUTICALSSERTRALINE HYDROCHLORIDE USP FORM-I

DMF 406902024

R L FINE CHEM PVT LTDSERTRALINE HYDROCHLORIDE FORM II

DMF 407642024

MATRIX PHARMACORP PRIVATE LTDSERTRALINE HYDROCHLORIDE USP (FORM-I)

DMF 426082025

CIPLA LTDInactiveSERTRALINE HYDROCHLORIDE USP (FORM-V)

DMF 144371999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveSERTRALINE HYDROCHLORIDE

DMF 161252002

PHF SAInactiveSERTRALINE HYDROCHLORIDE

DMF 167522003

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveSERTRALINE HYDROCHLORIDE FORM II

DMF 168482003

CIPLA LTDInactiveSERTRALINE HYDROCHLORIDE (FORM II)

DMF 173172004

CADILA HEALTHCARE LTDInactiveSERTRALINE HYDROCHLORIDE

DMF 180492005

CIPLA LTDInactiveSERTRALINE HYDROCHLORIDE (FORM-I)

DMF 184052005

RANBAXY LABORATORIES LTDInactiveSERTRALINE HYDROCHLORIDE DRUG SUBTANCE

DMF 189062005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveSERTRALINE HYDROCHLORIDE

DMF 190472005

ALP PHARM BEIJING CO LTDInactiveSERTRALINE HYDROCHLORIDE (DRUG SUBSTANCE, NON-STERILE)

DMF 221452008

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 3, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 50MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 30, 2006

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 30, 2006

#003 — EQ 25MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 30, 2006