01 2ACS DOBFAR SPA
02 1Abbott Laboratories
03 1Bristol Myers Squibb
04 2Chongqing DaXin Pharmaceutical
05 1Qilu Tianhe Pharmaceutical Co., Ltd.
06 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
01 1AMIKACIN 1.8 SULPHATE
02 3AMIKACIN SULFATE
03 1AMIKACIN SULFATE (1:2) USP
04 1AMIKACIN SULFATE USP
05 1AMIKACIN SULFATE USP, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT
06 1Amikacin Sulfate (1:1.8) USP, Non-Sterile Bulk Drug Substance
01 4China
02 2Italy
03 2U.S.A
01 2Active
02 6Inactive
01 2Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13756
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-07-05
DMF Number : 13763
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22732
Submission : 2009-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13722
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13788
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21035
Submission : 2007-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-25
Pay. Date : 2013-11-18
DMF Number : 20874
Submission : 2007-09-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27776
Submission : 2013-11-27
Status : Inactive
Type : II
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