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List of Drug Master Files (DMF) of Esomeprazole Magnesium Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS FORM)

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) USP

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS) [PROCESS-3]

ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE)

ESOMEPRAZOLE MAGNESIUM AMORPHOUS (PROCESS-2) USP

ESOMEPRAZOLE MAGNESIUM AMORPHOUS-USP

ESOMEPRAZOLE MAGNESIUM DELAYED - RELEASE PELLETS

ESOMEPRAZOLE MAGNESIUM USP

ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS)

ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS I)

ESOMEPRAZOLE MAGNESIUM USP (AMORPHOUS) (PROCESS II)

ESOMEPRAZOLE MAGNESIUM USP, NON-STERILE, BULK DRUG SUBSTANCE

ESOMEPRAZOLE MAGNESIUM [AMORPHOUS] [PRODUCT CODE: ADR]

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INDIA

UNITED STATES

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Active

Inactive

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Complete

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Request an Update of Your Company Information, Events & Sales Content

DMF Number

29639

Status

Active

Submission Date

2015-09-01

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

17278

Status

Inactive

Submission Date

2004-03-31

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

19192

Status

Inactive

Submission Date

2006-02-21

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

23994

Status

Active

Submission Date

2010-07-26

GDUFA DMF Review

Complete

GDUFA Review Date

2013-02-07

GDUFA Payment Date

2013-01-16

Type

II

Supporting Information

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DMF Number

24746

Status

Inactive

Submission Date

2011-03-11

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

28127

Status

Active

Submission Date

2014-03-31

GDUFA DMF Review

Complete

GDUFA Review Date

2014-07-07

GDUFA Payment Date

2014-04-21

Type

II

Supporting Information

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DMF Number

21375

Status

Inactive

Submission Date

2008-05-23

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

23448

Status

Active

Submission Date

2010-05-26

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

View All

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DMF Number

28054

Status

Active

Submission Date

2014-03-29

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

View All

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DMF Number

30020

Status

Active

Submission Date

2015-12-10

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

27925

Status

Inactive

Submission Date

2014-01-17

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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DMF Number

23120

Status

Active

Submission Date

2009-09-16

GDUFA DMF Review

Complete

GDUFA Review Date

2014-03-25

GDUFA Payment Date

2014-03-13

Type

II

Supporting Information

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DMF Number

27954

Status

Active

Submission Date

2014-03-13

GDUFA DMF Review

Complete

GDUFA Review Date

2014-05-01

GDUFA Payment Date

2014-02-12

Type

II

Supporting Information

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DMF Number

18559

Status

Inactive

Submission Date

2005-08-03

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

30175

Status

Active

Submission Date

2016-05-31

GDUFA DMF Review

Complete

GDUFA Review Date

2016-07-28

GDUFA Payment Date

2016-05-04

Type

II

Supporting Information

Request an Update of Your Company Information, Events & Sales Content

DMF Number

23110

Status

Active

Submission Date

2009-09-14

GDUFA DMF Review

Complete

GDUFA Review Date

2018-09-21

GDUFA Payment Date

2018-09-17

Type

II

Supporting Information

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD

Request an Update of Your Company Information, Events & Sales Content

DMF Number

30901

Status

Active

Submission Date

2016-09-15

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

Supporting Information

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