01 2ACS DOBFAR SPA
02 1Aurobindo Pharma Limited
03 1CSPC Pharmaceutical Group
04 1Hanmi Pharmaceutical
05 1Kyongbo Pharmaceutical Co., Ltd
06 1Lupin Ltd
07 1Nectar Lifesciences
08 1Orchid Pharma
09 1Qilu Antibiotics Pharmaceutical Co., Ltd.
10 1Sandoz B2B
11 1Wockhardt
12 1Zhuhai United Laboratories Co ., Ltd.
01 2CEFOTAXIME ACID
02 2CEFOTAXIME SODIUM (STERILE)
03 3CEFOTAXIME SODIUM STERILE
04 1CEFOTAXIME SODIUM USP
05 1CEFOTAXIME SODIUM USP (STERILE) DRUG SUBSTANCE
06 1CEFOTAXIME SODIUM, STERILE API
07 1CEFOTAXIME SODIUM, USP (STERILE BULK)
08 1STERILE CEFOTAXIME SODIUM
09 1STERILE CEFOTAXIME SODIUM USP
01 3China
02 5India
03 2Italy
04 2South Korea
05 1Switzerland
01 5Active
02 8Inactive
01 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 15272
Submission : 2001-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 14367
Submission : 1999-08-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18154
Submission : 2005-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12632
Submission : 1997-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13219
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24748
Submission : 2011-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17888
Submission : 2004-12-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20480
Submission : 2007-03-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21202
Submission : 2007-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16839
Submission : 2003-09-09
Status : Inactive
Type : II
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