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CITALOPRAM HYDROBROMIDE

NDA

CITALOPRAM HYDROBROMIDE | N021763 | BIOVAIL LABORATORIES INTERNATIONAL SRL

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain16 active DMFs14 inactive

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

H LUNDBECK ASCITALOPRAM HYDROBROMIDE

DMF 123841997

JUBILANT BIOSYS LTDCITALOPRAM HYDROBROMIDE USP

DMF 155872001

APITORIA PHARMA PRIVATE LTDCITALOPRAM HYDROBROMIDE USP

DMF 168502003

SUN PHARMACEUTICAL INDUSTRIES LTDCITALOPRAM HYDROBROMIDE USP

DMF 170742004

NATCO PHARMA LTDCITALOPRAM HYDROBROMIDE

DMF 171852004

HETERO DRUGS LTDCITALOPRAM HYDROBROMIDE (PROCESS I)

DMF 179792005

APITORIA PHARMA PRIVATE LTDCITALOPRAM HYDROBROMIDE USP (ROUTE-1)

DMF 195882006

JUBILANT PHARMOVA LTDCITALOPRAM HYDROBROMIDE (DGR) USP

DMF 200132006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCITALOPRAM HYDROBROMIDE USP

DMF 205862007

MATRIX PHARMACORP PRIVATE LTDCITALOPRAM HYDROBROMIDE USP

DMF 211652007

DR REDDYS LABORATORIES LTDCITALOPRAM HYDROBROMIDE USP

DMF 226582009

ARCH PHARMALABS LTDCITALOPRAM HYDROBROMIDE USP (CYANO ROUTE)

DMF 235662010

WUXI JIDA PHARMACEUTICAL CO LTDCITALOPRAM HYDROBROMIDE

DMF 239792010

HETERO DRUGS LTDCITALOPRAM HYDROBROMIDE (PROCESS II)

DMF 250882011

VIRUPAKSHA ORGANICS LTDCITALOPRAM HYDROBROMIDE

DMF 369252023

CIPLA LTDCITALOPRAM HYDROBROMIDE USP

DMF 381002023

CIPLA LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 158132002

SUMITOMO CHEMICAL CO LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 158362002

ARCH PHARMALABS LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 160452002

CIPLA LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 165532003

FERMION OYInactiveCITALOPRAM HYDROBROMIDE

DMF 167002003

FABBRICA ITALIANA SINTETICI SPAInactiveCITALOPRAM

DMF 167172003

WOCKHARDT LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 167882003

MYLAN LABORATORIES LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 169612003

WOCKHARDT LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 169792003

HEUMANN PHARMA GMBHInactiveCITALOPRAM HYDROBROMIDE

DMF 171042004

RANBAXY LABORATORIES LTDInactiveCITALOPRAM HYDROBROMIDE

DMF 173342004

ESTEVE QUIMICA SAInactiveCITALOPRAM HYDROBROMIDE

DMF 175112004

JIANGSU JIWA RINTECH PHARMACEUTICAL CO LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 200942006

IPCA LABORATORIES LTDInactiveCITALOPRAM HYDROBROMIDE USP

DMF 241212010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 19, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 10MG BASE

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Dec 20, 2005

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

RLD

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Dec 20, 2005

#003 — EQ 40MG BASE

RLD

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Dec 20, 2005