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CITALOPRAM HYDROBROMIDE

ANDA

CITALOPRAM HYDROBROMIDE | A077031 | AUROBINDO PHARMA LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CELEXA(TE code: AB)

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
Oct 29, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 10MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 28, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2004

#003 — EQ 40MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Oct 28, 2004