01 1ACS DOBFAR SPA
02 3Aurobindo Pharma Limited
03 1Farmastur 2010, S.L.
04 2Istituto Biochimico Italiano Giovanni Lorenzini SpA
05 3Mustafa Nevzat Ilac Sanayi A S
06 1Qilu Tianhe Pharmaceutical Co., Ltd.
07 1Sandoz B2B
08 1Zhejiang Hisun Pharmaceutical
09 1Zhuhai United Laboratories Co ., Ltd.
01 1STERILE SULBACTAM SODIUM
02 1SULBACTAM SODIUM (NON-STERILE API)
03 2SULBACTAM SODIUM (NON-STERILE)
04 1SULBACTAM SODIUM (STERILE)
05 1SULBACTAM SODIUM STERILE
06 1SULBACTAM SODIUM STERILE USP
07 2SULBACTAM SODIUM USP
08 1SULBACTAM SODIUM USP (NON-STERILE BULK)
09 1SULBACTAM SODIUM USP (STERILE BULK)
10 1SULBACTAM SODIUM USP (STERILE) BULK
11 1SULBACTAM SODIUM USP (STERILE) PROCESS-II
12 1SULBACTAM SODIUM USP, NON-STERILE
01 3China
02 3India
03 3Italy
04 1Spain
05 1Switzerland
06 3Turkey
01 7Active
02 7Inactive
01 2Complete
02 12Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16452
Submission : 2003-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39513
Submission : 2024-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19805
Submission : 2006-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19608
Submission : 2006-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14974
Submission : 2000-08-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-23
Pay. Date : 2020-05-18
DMF Number : 34192
Submission : 2020-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17189
Submission : 2004-03-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16587
Submission : 2003-05-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-11
Pay. Date : 2015-05-26
DMF Number : 29231
Submission : 2015-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16532
Submission : 2003-04-01
Status : Inactive
Type : II
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