01 2ACS DOBFAR SPA
02 2Aurobindo Pharma Limited
03 1Bayer AG
04 1Bristol Myers Squibb
05 2Fresenius Kabi AB Brunna
06 1GSK
07 1Istituto Biochimico Italiano Giovanni Lorenzini SpA
08 1Mustafa Nevzat Ilac Sanayi A S
09 1Pfizer Inc
10 1Sandoz B2B
11 1Sterile India Pvt. Ltd
12 1Wyeth Pharmaceuticals Inc
01 1AMPICILLIN AND SULBACTAM (STERILE BULK)
02 1AMPICILLIN AND SULBACTAM FOR INJECTION USP (STERILE BULK MIXTURE 2:1)
03 4AMPICILLIN SODIUM
04 1AMPICILLIN SODIUM (STERILE BULK)
05 1AMPICILLIN SODIUM (STERILE)
06 2AMPICILLIN SODIUM STERILE
07 1AMPICILLIN SODIUM STERILE CRYSTALLINE (BULK)
08 1AMPICILLIN SODIUM USP (STERILE)
09 1AMPICILLIN SODIUM USP (STERILE) BULK
10 1AMPICILLIN SODIUM/SULBACTAM SODIUM
11 1STERILE MIXTURE OF AMPICILLIN SODIUM AND SULBACTAM SODIUM (2:1)
01 1Germany
02 3India
03 3Italy
04 2Sweden
05 1Switzerland
06 1Turkey
07 3U.S.A
08 1United Kingdom
01 9Active
02 6Inactive
01 2Complete
02 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16451
Submission : 2003-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13661
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20300
Submission : 2007-02-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-26
Pay. Date : 2014-05-19
DMF Number : 20211
Submission : 2007-01-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8109
Submission : 1989-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25477
Submission : 2011-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23287
Submission : 2009-11-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13742
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-20
Pay. Date : 2023-04-17
DMF Number : 13754
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29984
Submission : 2018-05-04
Status : Active
Type : II
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