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01 2ALP Pharm

02 2Amneal Pharmaceuticals

03 4JOYANG LABORATORIES

04 2North China Pharmaceutical Huasheng Co Ltd

05 1Pfizer Inc

06 1SIGMA TAU

07 2WORLD JIANGSU INDUSTRY CO LTD

08 5Xellia Pharmaceuticals ApS

09 1Yancheng Youhua Pharma and Chemical Tech Co Ltd

10 2Blank

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PharmaCompass

01

Pharmtech & Ingredients
Not Confirmed

02

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03

Pharmtech & Ingredients
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05

Pharmtech & Ingredients
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05

Pharmtech & Ingredients
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GDUFA

DMF Review : Complete

Rev. Date : 2015-02-06

Pay. Date : 2014-11-10

DMF Number : 28615

Submission : 2014-08-29

Status : Active

Type : II

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06

Pharmtech & Ingredients
Not Confirmed

09

Pharmtech & Ingredients
Not Confirmed

10

Pharmtech & Ingredients
Not Confirmed

10

Pharmtech & Ingredients
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-04-23

Pay. Date : 2013-09-23

DMF Number : 27510

Submission : 2013-09-11

Status : Active

Type : II

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