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ESOMEPRAZOLE SODIUM

ANDA

ESOMEPRAZOLE SODIUM | A205379 | ACCORD HEALTHCARE INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain12 active DMFs4 inactive

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

SUN PHARMACEUTICAL INDUSTRIES LTDESOMEPRAZOLE SODIUM

DMF 231992009

JUBILANT PHARMOVA LTDESOMEPRAZOLE SODIUM

DMF 236282010

HETERO DRUGS LTDESOMEPRAZOLE SODIUM

DMF 246412011

EMCURE PHARMACEUTICALS LTDESOMEPRAZOLE SODIUM

DMF 249182011

APITORIA PHARMA PRIVATE LTDESOMEPRAZOLE SODIUM (NON-STERILE DRUG SUBSTANCE)

DMF 261022012

EMCURE PHARMACEUTICALS LTDESOMEPRAZOLE SODIUM (PROCESS II)

DMF 273882013

PCASESOMEPRAZOLE SODIUM

DMF 283752014

ZHEJIANG LEPU PHARMACEUTICAL CO LTDESOMEPRAZOLE SODIUM (NON-STERILE BULK DRUG SUBSTANCE)

DMF 290822015

STERILE INDIA PVT LTDESOMEPRAZOLE SODIUM (STERILE)

DMF 299742016

HAINAN POLY PHARM CO LTDESOMEPRAZOLE SODIUM

DMF 350592020

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDESOMEPRAZOLE SODIUM NON-STERILE BULK DRUG SUBSTANCE

DMF 350732020

SHANDONG NEW TIME PHARMACEUTICAL CO LTDESOMEPRAZOLE SODIUM

DMF 360692021

JUBILANT ORGANOSYS LTDInactiveESOMEPRAZOLE SODIUM

DMF 219862009

CADILA HEALTHCARE LTDInactiveESOMEPRAZOLE SODIUM

DMF 245382011

METROCHEM API PRIVATE LTDInactiveESOMEPRAZOLE SODIUM

DMF 280262014

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveESOMEPRAZOLE SODIUM

DMF 306672016

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 2, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 40MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Sep 25, 2015

No patent or exclusivity listings for this strength.