Tox21_300584 | API DMFs | US Drug Master File (DMF) Details

DR REDDYS LABORATORIES LTD

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India Flag India

Contact Supplier

Virtual Booth

Website

PIOGLITAZONE HYDROCHLORIDE USP

EU DMF,CDMF,JDMF Available

DMF Number

21295

Status

Active

Submission Date

2008-01-31

GDUFA DMF Review

Complete

GDUFA Review Date

2014-01-14

GDUFA Payment Date

2013-12-31

Type

II

IFT Annual Expo

Participation Not Confirmed

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DR REDDYS LABORATORIES LTD

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India Flag India

Contact Supplier

Virtual Booth

Website

PIOGLITAZONE HYDROCHLORIDE

EU DMF,CDMF,JDMF Available

DMF Number

16675

Status

Inactive

Submission Date

2003-07-02

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

IFT Annual Expo

Participation Not Confirmed

Update your events

AARTI DRUGS LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

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DMF Number

26192

Status

Inactive

Submission Date

2012-07-03

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

AUROBINDO PHARMA LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP (NON STERILE DRUG SUBSTANCE)

Supporting Information : Click here to upload a PDF

DMF Number

22865

Status

Active

Submission Date

2009-06-12

GDUFA DMF Review

Complete

GDUFA Review Date

2014-01-27

GDUFA Payment Date

2014-01-16

Type

II

BIOCON LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

Supporting Information : Click here to upload a PDF

DMF Number

23278

Status

Active

Submission Date

2009-11-16

GDUFA DMF Review

Complete

GDUFA Review Date

2014-05-19

GDUFA Payment Date

2014-02-21

Type

II

BIOCON LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

Supporting Information : Click here to upload a PDF

DMF Number

16635

Status

Active

Submission Date

2003-06-11

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

CADILA HEALTHCARE LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

Supporting Information : Click here to upload a PDF

DMF Number

22041

Status

Active

Submission Date

2008-09-24

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

CIPLA LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

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DMF Number

16672

Status

Active

Submission Date

2003-06-30

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

ERREGIERRE SPA

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Italy Flag Italy

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

Supporting Information : Click here to upload a PDF

DMF Number

19343

Status

Inactive

Submission Date

2006-04-04

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

HETERO LABS LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

EUDMF Available

DMF Number

21534

Status

Inactive

Submission Date

2008-04-15

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

HETERO LABS LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE (PROCESS-II)

EUDMF Available

DMF Number

30333

Status

Active

Submission Date

2016-03-03

GDUFA DMF Review

Complete

GDUFA Review Date

2016-07-28

GDUFA Payment Date

2016-03-02

Type

II

IND SWIFT LABORATORIES LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

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DMF Number

18379

Status

Active

Submission Date

2005-05-21

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

LUPIN LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

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DMF Number

19626

Status

Active

Submission Date

2006-06-30

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

MACLEODS PHARMACEUTICALS LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

Supporting Information : Click here to upload a PDF

DMF Number

23668

Status

Active

Submission Date

2010-03-31

GDUFA DMF Review

Complete

GDUFA Review Date

2014-02-07

GDUFA Payment Date

2014-01-29

Type

II

MOREPEN LABORATORIES LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

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DMF Number

17701

Status

Inactive

Submission Date

2004-09-23

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

MSN ORGANICS PRIVATE LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP [ROUTE CODE "PG"]

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DMF Number

24181

Status

Active

Submission Date

2010-09-15

GDUFA DMF Review

Complete

GDUFA Review Date

2017-03-17

GDUFA Payment Date

2017-02-27

Type

II

MYLAN LABORATORIES LTD

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United States Flag United States

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

Supporting Information : Click here to upload a PDF

DMF Number

21474

Status

Active

Submission Date

2008-03-22

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

PAR ACTIVE TECHNOLOGIES PRIVATE LTD

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United States Flag United States

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE

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DMF Number

22924

Status

Active

Submission Date

2009-07-06

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

SUN PHARMACEUTICAL INDUSTRIES LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

Supporting Information : Click here to upload a PDF

DMF Number

16682

Status

Inactive

Submission Date

2003-07-03

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

SIGNA SA DE CV

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Mexico Flag Mexico

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

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DMF Number

21603

Status

Active

Submission Date

2008-05-08

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

TEVA PHARMACEUTICAL INDUSTRIES LTD

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Israel Flag Israel

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

Supporting Information : Click here to upload a PDF

DMF Number

16688

Status

Active

Submission Date

2003-07-08

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

USV PRIVATE LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP (EXTRA PURE)

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DMF Number

19250

Status

Active

Submission Date

2006-03-10

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

USV PRIVATE LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

Supporting Information : Click here to upload a PDF

DMF Number

16684

Status

Active

Submission Date

2003-07-08

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

WOCKHARDT LTD

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India Flag India

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

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DMF Number

16793

Status

Active

Submission Date

2003-08-28

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

ZHEJIANG HISUN PHARMACEUTICAL CO LT...

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China Flag China

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

Supporting Information : Click here to upload a PDF

DMF Number

27746

Status

Inactive

Submission Date

2013-12-02

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

ZHEJIANG HUAHAI PHARMACEUTICAL CO L...

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China Flag China

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE USP

Product Presentation

DMF Number

27504

Status

Active

Submission Date

2013-09-19

GDUFA DMF Review

Complete

GDUFA Review Date

2014-02-21

GDUFA Payment Date

2013-09-27

Type

II

ZHEJIANG HUAYI PHARMACEUTICAL CO LT...

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China Flag China

Post An Enquiry

Virtual Booth

PIOGLITAZONE HYDROCHLORIDE

Supporting Information : Click here to upload a PDF

DMF Number

19558

Status

Active

Submission Date

2006-06-28

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

Find

List of Drug Master Files (DMF) of Tox21_300584 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

21295

Active

2008-01-31

Complete

2014-01-14

2013-12-31

II

16675

Inactive

2003-07-02

N/A

II

26192

Inactive

2012-07-03

N/A

II

22865

Active

2009-06-12

Complete

2014-01-27

2014-01-16

II

23278

Active

2009-11-16

Complete

2014-05-19

2014-02-21

II

16635

Active

2003-06-11

N/A

II

22041

Active

2008-09-24

N/A

II

16672

Active

2003-06-30

N/A

II

19343

Inactive

2006-04-04

N/A

II

21534

Inactive

2008-04-15

N/A

II

30333

Active

2016-03-03

Complete

2016-07-28

2016-03-02

II

18379

Active

2005-05-21

N/A

II

19626

Active

2006-06-30

N/A

II

23668

Active

2010-03-31

Complete

2014-02-07