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01 1AbbVie Inc

02 1Actavis Inc

03 1Apotex Pharmachem

04 1CKD Bio Corporation

05 2Catalent Pharma Solutions

06 1Concord Biotech

07 2Curia

08 1Fujian Kerui Pharmaceutical Co Ltd

09 1GALENA AS

10 1Hangzhou Zhongmei Huadong Pharmaceutical

11 2North China Pharmaceutical Co., Ltd.

12 1North China Pharmaceutical Huasheng Co Ltd

13 1Ruibang Laboratories

14 1Sandoz B2B

15 4Teva API

16 2Zhejiang Ruibang Laboratories

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PharmaCompass

02

American Pharma Summit
Not Confirmed

04

American Pharma Summit
Not Confirmed

05

American Pharma Summit
Not Confirmed

06

American Pharma Summit
Not Confirmed

06

American Pharma Summit
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-01-16

Pay. Date : 2013-12-12

DMF Number : 13789

Submission : 1998-09-01

Status : Active

Type : II

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10

American Pharma Summit
Not Confirmed