01 2Actavis Inc
02 2Chongqing DaXin Pharmaceutical
03 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
04 1Livzon New North River Pharmaceutical
05 1Teva API
06 2Xellia Pharmaceuticals ApS
07 1Zhejiang Hisun Pharmaceutical
08 4Blank
01 6TOBRAMYCIN
02 1TOBRAMYCIN (NON-STERILE, BULK FORM)
03 1TOBRAMYCIN BASE
04 1TOBRAMYCIN BASE USP (NON-STERILE BULK)
05 1TOBRAMYCIN FORM-1 USP
06 1TOBRAMYCIN SULPHATE USP (NON-STERILE BULK)
07 1TOBRAMYCIN SULPHATE, NON-STERILE BULK
08 1TOBRAMYCIN SULPHATE, USP STERILE BULK
09 1TOBRAMYCIN USP
01 5China
02 2Denmark
03 2Ireland
04 1Israel
05 4Blank
01 6Active
02 8Inactive
01 5Complete
02 9Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-02
Pay. Date : 2013-03-26
DMF Number : 13774
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-24
Pay. Date : 2020-09-29
DMF Number : 35042
Submission : 2020-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20724
Submission : 2007-07-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-13
DMF Number : 13713
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-12
Pay. Date : 2012-11-15
DMF Number : 15629
Submission : 2001-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-06
Pay. Date : 2012-10-31
DMF Number : 15021
Submission : 2000-09-12
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13740
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13739
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12128
Submission : 1996-09-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7578
Submission : 1988-07-07
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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