01 1ALP Pharm
02 1BIOTIKA a.s.
03 1CULTOR FOOD SCIENCE INC
04 1Hangzhou Zhongmei Huadong Pharmaceutical
05 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
06 1North China Pharmaceutical Huasheng Co Ltd
07 1Shandong Luxi Pharmaceutical Co.,Ltd.
08 1Shandong Ruizhi Pharmaceutical Technology
09 1WORLD JIANGSU INDUSTRY CO LTD
10 2Xellia Pharmaceuticals ApS
11 1Yancheng Youhua Pharma and Chemical Tech Co Ltd
12 1Blank
01 7POLYMYXIN B SULFATE
02 4POLYMYXIN B SULFATE USP
03 1POLYMYXIN B SULFATE, STERILE
04 1Polymyxin B Sulfate USP (Non-Sterile Drug Substance)
01 8China
02 2Denmark
03 1Slovakia
04 1U.S.A
05 1Blank
01 11Active
02 2Inactive
01 4Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23997
Submission : 2010-07-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-29
Pay. Date : 2013-12-11
DMF Number : 23876
Submission : 2010-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-20
Pay. Date : 2013-11-08
DMF Number : 22030
Submission : 2008-10-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38019
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35892
Submission : 2021-07-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31587
Submission : 2017-03-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 14187
Submission : 1999-06-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13536
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28616
Submission : 2014-09-08
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31683
Submission : 2017-03-21
Status : Active
Type : II
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