01 1ACS DOBFAR SPA
02 1Fresenius Kabi AB Brunna
03 1Qilu Pharmaceutical
04 2Qilu Tianhe Pharmaceutical Co., Ltd.
05 1Sandoz B2B
06 1Sterile India Pvt. Ltd
01 1PIPERACILLIN & TAZOBACTAM SODIUM (STERILE)
02 1PIPERACILLIN AND TAZOBACTAM (STERILE BULK)
03 1PIPERACILLIN SODIUM & TAZOBACTAM SODIUM (8:1), STERILE
04 1PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1)
05 1PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (PROCESS IV)
06 1PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM (8:1) (STERILE API)
07 1PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM (8:1) STERILE LYOPHILIZED
01 3China
02 1India
03 1Italy
04 1Sweden
05 1Switzerland
01 7Active
01 3Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36317
Submission : 2022-10-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-31
Pay. Date : 2013-12-17
DMF Number : 25545
Submission : 2011-11-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20432
Submission : 2007-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-14
Pay. Date : 2019-02-20
DMF Number : 33540
Submission : 2019-02-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-07
Pay. Date : 2013-01-09
DMF Number : 26009
Submission : 2012-03-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18903
Submission : 2005-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29994
Submission : 2016-11-28
Status : Active
Type : II
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