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01 1ACS DOBFAR SPA
02 1Bristol Myers Squibb
03 2Chongqing DaXin Pharmaceutical
04 1Nektar Therapeutics
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01 3AMIKACIN BASE
02 1AMIKACIN HYDROCHLORIDE, NON-STERILE BULK DRUG
03 1AMIKACIN PULMONARY DELIVERY SYSTEM
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01 2China
02 1Italy
03 2U.S.A
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01 1Active
02 4Inactive
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01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13762
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13527
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14007
Submission : 1999-03-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13760
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20987
Submission : 2007-10-31
Status : Inactive
Type : II
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