Tazarotene

WATSON PHARMA PRIVATE LTD

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Ireland Flag Ireland

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Virtual Booth

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DMF Number

20063

Status

Inactive

Submission Date

2006-12-13

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

CARDINAL HEALTH PTS LLC

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United States Flag United States

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TAZAROTENE 1.5 MG AND 4.5 MG CAPSULES

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DMF Number

16864

Status

Inactive

Submission Date

2003-09-22

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

BASF SE

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Virtual Booth

TAZAROTENE

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DMF Number

19089

Status

Inactive

Submission Date

2006-01-03

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

GLENMARK LIFE SCIENCES LTD

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India Flag India

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TAZAROTENE

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DMF Number

21422

Status

Active

Submission Date

2008-03-14

GDUFA DMF Review

Complete

GDUFA Review Date

2014-12-05

GDUFA Payment Date

2014-08-20

Type

II

OLON SPA

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Italy Flag Italy

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TAZAROTENE

Product Presentation

DMF Number

29600

Status

Active

Submission Date

2015-07-30

GDUFA DMF Review

Complete

GDUFA Review Date

2017-04-24

GDUFA Payment Date

2017-04-03

Type

II

PCAS

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France Flag France

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TAZAROTENE

US DMF For Reference- Available

DMF Number

25161

Status

Active

Submission Date

2011-07-25

GDUFA DMF Review

Complete

GDUFA Review Date

2015-02-02

GDUFA Payment Date

2013-09-30

Type

II

PIRAMAL HEALTHCARE CANADA LTD

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India Flag India

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TAZAROTENE

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DMF Number

24874

Status

Inactive

Submission Date

2011-04-15

GDUFA DMF Review

N/A

GDUFA Review Date

GDUFA Payment Date

Type

II

TARO PHARMACEUTICAL INDUSTRIES LTD

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Israel Flag Israel

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TAZAROTENE, MICRONIZED

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DMF Number

28470

Status

Active

Submission Date

2014-10-31

GDUFA DMF Review

Complete

GDUFA Review Date

2015-01-05

GDUFA Payment Date

2014-10-30

Type

Find

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

20063

Inactive

2006-12-13

N/A

II

16864

Inactive

2003-09-22

N/A

II

BASF SE

19089

Inactive

2006-01-03

N/A

II

21422

Active

2008-03-14

Complete

2014-12-05

2014-08-20

II

29600

Active

2015-07-30

Complete

2017-04-24

2017-04-03

II

25161

Active

2011-07-25

Complete

2015-02-02

2013-09-30

II

24874

Inactive

2011-04-15

N/A

II

28470

Active

2014-10-31

Complete

2015-01-05

2014-10-30

II