01 1Aurobindo Pharma Limited
02 1Chongqing Shenghuaxi Pharma. Co., Ltd
03 5Curia
04 1FangYuan Pharmaceutical
05 2Fuan Pharmaceutical
06 1Orchid Pharma
07 2Teva API
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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