01 1ACS DOBFAR SPA
02 1Auronext Pharma Private Limited
03 2Emnar Pharma
04 1Glenmark Life Sciences
05 1Global Calcium
06 1Hospira, Inc.
07 1Luitpold Pharmaceuticals, Inc.
08 1RANBAXY LABORATORIES LIMITED
09 5SAFC
10 1SOLVAY -Technology Solutions
11 1Savior Lifetec Corporation
12 1Unimark Remedies Limited
13 1VM Chemicals
01 1EX-CELL 325 PF CHO (MODIFIED) SERUM-FREE PROTEIN-FREE W/L-GLUTAMINE W/O SODIUM BICARBONATE
02 1EX-CELL XJEM WITHOUT L-GLUTAMINE, WITHOUT SODIUM BICARBONATE
03 1EX-CELL(TM) 293 MEDIUM W/L-GLUTAMINE, W/O SODIUM BICARBONATE
04 1EX-CELL(TM) 301 COMPLETE MEDIUM W/ L-GLUTAMINE, W/O SODIUM BICARBONATE
05 1EX-CELL(TM) NSO SERUM-FREE, CHEMICALLY DEFINED W/O L-GLUTAMINE W/O SODIUM BICARBONATE
06 1NEUTRA-CAINE (SODIUM BICARBONATE INJECTION) USP 7.5%
07 1SODIUM BICARBONATE
08 2SODIUM BICARBONATE (STERILE)
09 1SODIUM BICARBONATE BP
10 4SODIUM BICARBONATE USP
11 1SODIUM BICARBONATE USP (STERILE)
12 1SODIUM BICARBONATE, STERILE
13 1STERILE MIXTURE FOR IMIPENEM, CILASTATIN SODIUM AND SODIUM BICARBONATE (DRUG PRODUCT INTERMEDIATE)
14 1STERILE SODIUM BICARBONATE USP
01 1Germany
02 8India
03 1Italy
04 1Taiwan
05 7U.S.A
01 7Active
02 11Inactive
01 1Complete
02 17Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12585
Submission : 1997-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32237
Submission : 2017-12-13
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-24
Pay. Date : 2021-05-17
DMF Number : 32436
Submission : 2018-01-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39780
Submission : 2024-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38670
Submission : 2023-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15236
Submission : 2000-12-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19557
Submission : 2006-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16457
Submission : 2003-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28381
Submission : 2014-06-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29038
Submission : 2015-01-06
Status : Active
Type : II
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