01 1Aurobindo Pharma Limited
02 1Chongqing Shenghuaxi Pharma. Co., Ltd
03 5Curia
04 1FangYuan Pharmaceutical
05 2Fuan Pharmaceutical
06 1Orchid Pharma
07 2TAPI Technology & API Services
01 3AZTREONAM
02 2AZTREONAM ALFA FORM
03 2AZTREONAM BETA FORM
04 1AZTREONAM HYDRATED NON-STERILE ALPHA-FORM
05 3AZTREONAM USP
06 1AZTREONAM USP (NON-STERILE BULK DRUG SUBSTANCE)
07 1AZTREONAM, NON-STERILE BULK DRUG SUBSTANCE
01 4China
02 2India
03 2Israel
04 5U.S.A
01 9Active
02 4Inactive
01 6Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-12
Pay. Date : 2023-07-31
DMF Number : 38649
Submission : 2023-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2013-10-30
DMF Number : 26856
Submission : 2013-10-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38055
Submission : 2023-05-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-13
Pay. Date : 2019-06-03
DMF Number : 33762
Submission : 2019-04-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-09
Pay. Date : 2019-05-17
DMF Number : 33731
Submission : 2019-04-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17184
Submission : 2004-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39731
Submission : 2024-05-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-28
Pay. Date : 2013-09-30
DMF Number : 27508
Submission : 2013-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-12-03
DMF Number : 19342
Submission : 2006-04-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16751
Submission : 2003-08-08
Status : Inactive
Type : II
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