01 1Aurobindo Pharma Limited
02 1DMFs Not Supported
03 2Hospira, Inc.
04 1Jiangxi Fushine Pharmaceutical
05 1Jiangxi Fushine Pharmaceutical Co. Ltd
06 1Otsuka Chemical Co Ltd
07 1Qilu Pharmaceutical
08 4Qilu Tianhe Pharmaceutical Co., Ltd.
09 1Shandong Anxin Pharmaceutical
10 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.
11 2Zhejiang Hisun Pharmaceutical
01 3TAZOBACTAM
02 2TAZOBACTAM (NON-STERILE API)
03 1TAZOBACTAM (TRIAZOLE PROCESS)
04 1TAZOBACTAM ACID (PROCESS I, NON-STERILE BULK)
05 1TAZOBACTAM ACID (PROCESS V, NON-STERILE API)
06 1TAZOBACTAM ACID USP
07 1TAZOBACTAM HEMIHYDRATE USP
08 1TAZOBACTAM SODIUM (NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)
09 2TAZOBACTAM SODIUM (STERILE API)
10 2TAZOBACTAM USP
11 1TAZOBACTAM USP (BH ROUTE)
01 11China
02 1India
03 1Japan
04 2U.S.A
05 1Blank
01 9Active
02 7Inactive
01 7Complete
02 9Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-16
Pay. Date : 2021-12-13
DMF Number : 19823
Submission : 2006-09-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-04
Pay. Date : 2019-07-31
DMF Number : 33978
Submission : 2019-07-30
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18506
Submission : 2005-07-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37889
Submission : 2023-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-20
Pay. Date : 2017-08-28
DMF Number : 31398
Submission : 2017-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-21
Pay. Date : 2019-05-21
DMF Number : 33785
Submission : 2019-07-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-26
Pay. Date : 2013-11-22
DMF Number : 27140
Submission : 2013-04-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-08
DMF Number : 20428
Submission : 2007-04-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-06
Pay. Date : 2022-04-14
DMF Number : 36268
Submission : 2022-05-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38374
Submission : 2023-09-12
Status : Active
Type : II
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