01 2ACS DOBFAR SPA
02 2Hospira, Inc.
03 2Orchid Pharma
04 1Qilu Antibiotics Pharmaceutical Co., Ltd.
05 1RANBAXY LABORATORIES LIMITED
06 1SOLVAY -Technology Solutions
07 1Sandoz B2B
08 1Savior Lifetec Corporation
09 1Takeda Pharmaceutical
01 1CEFTAZIDIME + SODIUM CARBONATE (STERILE BULK)
02 1MEROPENEM + SODIUM CARBONATE (STERILE BULK)
03 1MEROPENEM AND SODIUM CARBONATE (STERILE BULK)
04 1MEROPENEM WITH SODIUM CARBONATE
05 1MEROPENEM WITH SODIUM CARBONATE, STERILE BLEND
06 2SODIUM CARBONATE (STERILE)
07 1SODIUM CARBONATE ANHYDROUS USNF (STERILE)
08 1SODIUM CARBONATE LYOPHILIZED STERILE
09 1SODIUM CARBONATE STERILE LYOPHILIZED
10 1SODIUM CARBONATE, ANHYDROUS
11 1STERILE ANHYDROUS SODIUM CARBONATE
01 1China
02 1Germany
03 3India
04 2Italy
05 1Japan
06 1Switzerland
07 1Taiwan
08 2U.S.A
01 5Active
02 7Inactive
01 2Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30487
Submission : 2016-08-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15623
Submission : 2001-09-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21709
Submission : 2008-07-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21699
Submission : 2008-07-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23295
Submission : 2009-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23293
Submission : 2009-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-21
Pay. Date : 2016-05-18
DMF Number : 28975
Submission : 2014-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21146
Submission : 2007-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2012-11-16
DMF Number : 21861
Submission : 2008-07-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5194
Submission : 1983-08-31
Status : Inactive
Type : II
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