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EPROSARTAN MESYLATE

ANDA

EPROSARTAN MESYLATE | A202012 | PHARMOBEDIENT CONSULTING LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs4 inactive

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

DISHMAN CARBOGEN AMCIS LTDEPROSARTAN MESYLATE

DMF 181552005

JUBILANT PHARMOVA LTDEPROSARTAN MESYLATE

DMF 228632009

HETERO DRUGS LTDEPROSARTAN MESYLATE

DMF 232742009

UNICHEM LABORATORIES LTDEPROSARTAN MESYLATE

DMF 238342010

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDEPROSARTAN MESYLATE

DMF 262302012

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveEPROSARTAN MESYLATE

DMF 167032003

LONZA LTDInactiveEPROSARTAN MESYLATE (ROUTE F)

DMF 167902003

LONZA AGInactiveEPROSARTAN MESYLATE (ROUTE F1)

DMF 180792005

MYLAN LABORATORIES LTDInactiveEPROSARTAN MESYLATE

DMF 240092010

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 21, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 400MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 16, 2011

No patent or exclusivity listings for this strength.

#002 — EQ 600MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 16, 2011