01 1ACS DOBFAR SPA
02 1Asymchem Laboratories
03 1Aurobindo Pharma Limited
04 1GLAND CHEMICALS PRIVATE LIMITED
05 1GLAND PHARMA LIMITED
06 1Hospira, Inc.
07 1JILIN ASYMCHEM LABORATORIES CO LTD
08 1Qilu Antibiotics Pharmaceutical Co., Ltd.
09 1Shandong Anhong Pharmaceutical
10 1Solara Active Pharma Sciences
11 1Sun Pharmaceutical Industries Limited
01 10ERTAPENEM SODIUM
02 1ERTAPENEM SODIUM (PROCESS I)
01 2China
02 5India
03 1Italy
04 3U.S.A
01 9Active
02 2Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-30
Pay. Date : 2015-04-17
DMF Number : 29102
Submission : 2015-04-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-03-03
DMF Number : 30311
Submission : 2016-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40191
Submission : 2024-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-20
Pay. Date : 2018-01-11
DMF Number : 32424
Submission : 2018-01-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27348
Submission : 2013-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37463
Submission : 2023-03-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2016-08-22
DMF Number : 30709
Submission : 2016-05-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-30
Pay. Date : 2022-08-19
DMF Number : 37232
Submission : 2022-08-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28391
Submission : 2014-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-25
Pay. Date : 2015-12-30
DMF Number : 30123
Submission : 2016-01-07
Status : Active
Type : II
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