01 3ACS DOBFAR SPA
02 1Antibioticos do Brasil Ltda
03 2Aurobindo Pharma Limited
04 2CSPC Pharmaceutical Group
05 1F. Hoffmann-La Roche
06 1Fresenius Kabi AB Brunna
07 1Hanmi Pharmaceutical
08 1Kyongbo Pharmaceutical Co., Ltd
09 1Lupin Ltd
10 3Nectar Lifesciences
11 2Orchid Pharma
12 1Qilu Antibiotics Pharmaceutical Co., Ltd.
13 3Sandoz B2B
14 3Sinopharm Weiqida Pharmaceutical Co Ltd
15 1Sterile India Pvt. Ltd
16 1Wockhardt
17 1Zhuhai United Laboratories Co ., Ltd.
01 17-ACT
02 4CEFTRIAXONE SODIUM
03 1CEFTRIAXONE SODIUM (NON-STERILE BULK) USP
04 1CEFTRIAXONE SODIUM (NON-STERILE)
05 1CEFTRIAXONE SODIUM (NON-STERILE) DRUG SUBSTANCE
06 2CEFTRIAXONE SODIUM (STERILE)
07 1CEFTRIAXONE SODIUM NON STERILE USP
08 4CEFTRIAXONE SODIUM STERILE
09 1CEFTRIAXONE SODIUM USP
10 1CEFTRIAXONE SODIUM USP (STERILE )
11 1CEFTRIAXONE SODIUM USP (STERILE BULK)
12 1CEFTRIAXONE SODIUM USP (STERILE)
13 1CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE
14 1CEFTRIAXONE SODIUM USP (STERILE) DRUG SUBSTANCE (PROCESS-II)
15 1CEFTRIAXONE SODIUM USP STERILE 100 GRAMS
16 2CEFTRIAXONE SODIUM, USP
17 1CEFTRIAXONE SODIUM, USP (STERILE BULK)
18 1DEACYL CEFTRIAXONE (7-ACT)
19 1STERILE CEFTRIAXONE SODIUM
20 1STERILE CEFTRIAXONE SODIUM USP
01 1Brazil
02 7China
03 10India
04 3Italy
05 2South Korea
06 1Sweden
07 4Switzerland
01 14Active
02 14Inactive
01 3Complete
02 25Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-21
DMF Number : 17541
Submission : 2004-07-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17259
Submission : 2004-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2014-04-18
DMF Number : 19627
Submission : 2006-07-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24354
Submission : 2010-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24134
Submission : 2010-08-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17257
Submission : 2004-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-29
Pay. Date : 2012-12-19
DMF Number : 20482
Submission : 2006-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16467
Submission : 2003-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4996
Submission : 1983-06-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16650
Submission : 2003-06-16
Status : Active
Type : II
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