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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

ESCITALOPRAM OXALATE

ANDA

Tentative Approval

ESCITALOPRAM OXALATE | A078313 | WATSON LABS

API Supply Chain26 active DMFs8 inactive

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

H LUNDBECK ASESCITALOPRAM OXALATE

DMF 141031999

CIPLA LTDESCITALOPRAM OXALATE USP

DMF 166362003

HETERO LABS LTDESCITALOPRAM OXALATE (PROCESS-I)

DMF 179602004

ZYDUS LIFESCIENCES LTDESCITALOPRAM OXALATE USP

DMF 181192005

MATRIX PHARMACORP PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 182132005

APITORIA PHARMA PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 190882005

JUBILANT BIOSYS LTDESCITALOPRAM OXALATE USP

DMF 194462006

NEULAND LABORATORIES LTDESCITALOPRAM OXALATE

DMF 196622006

ARCH PHARMALABS LTDESCITALOPRAM OXALATE

DMF 196632006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDESCITALOPRAM OXALATE USP

DMF 200812006

CADILA PHARMACEUTICALS LTDESCITALOPRAM OXALATE USP

DMF 224402009

JUBILANT BIOSYS LTDESCITALOPRAM OXALATE USP (ESP PROCESS)

DMF 228642009

MACLEODS PHARMACEUTICALS LTDESCITALOPRAM OXALATE

DMF 229002009

WUXI JIDA PHARMACEUTICAL CO LTDESCITALOPRAM OXALATE

DMF 255192011

DR REDDYS LABORATORIES LTDESCITALOPRAM OXALATE (PROCESS II)

DMF 258732012

HETERO LABS LTDESCITALOPRAM OXALATE (PROCESS II)

DMF 261852012

HEC PHARM CO LTDESCITALOPRAM OXALATE NON-STERILE BULK SUBSTANCE

DMF 284542014

MICRO LABS LTDESCITALOPRAM OXALATE USP

DMF 345682020

RUYUAN HEC PHARM CO LTDESCITALOPRAM OXALATE NON-STERILE BULK DRUG SUBSTANCE

DMF 351832020

VIRUPAKSHA ORGANICS LTDESCITALOPRAM OXALATE

DMF 366322022

CIPLA LTDESCITALOPRAM OXALATE USP (PROCESS-II)

DMF 389762023

SHODHANA LABORATORIES PRIVATE LTDESCITALOPRAM OXALATE

DMF 392002023

SMS PHARMACEUTICALS LTDESCITALOPRAM OXALATE USP

DMF 407212024

ZHEJIANG HAISEN PHARMACEUTICAL CO LTDESCITALOPRAM OXALATE

DMF 409232025

SYNERGENE ACTIVE INGREDIENTS PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 410482025

MAITHRI LABORATORIES PRIVATE LTDESCITALOPRAM OXALATE USP

DMF 413152025

DR REDDYS LABORATORIES LTDInactiveESCITALOPRAM OXALATE

DMF 183422005

LUPIN LTDInactiveESCITALOPRAM OXALATE USP

DMF 191052005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveESCITALOPRAM OXALATE USP

DMF 192512006

SANDOZ PRIVATE LTDInactiveESCITALOPRAM OXALATE

DMF 227572009

CADILA HEALTHCARE LTDInactiveESCITALOPRAM OXALATE (FORM -1)

DMF 232342009

MICRO LABS LTDInactiveESCITALOPRAM OXALATE

DMF 246842010

IPCA LABORATORIES LTDInactiveESCITALOPRAM OXALATE

DMF 256602012

TOKUYAMA CORPInactiveESCITALOPRAM OXALATE

DMF 318072017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 10, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 5MG BASE

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TABLET; ORAL | TA Date: 2008-03-03 00:00:00

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

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TABLET; ORAL | TA Date: 2008-03-03 00:00:00

#003 — EQ 20MG BASE

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TABLET; ORAL | TA Date: 2008-03-03 00:00:00