01 2ACS DOBFAR SPA
02 1Auronext Pharma Private Limited
03 1Choongwae Pharma Corporation
04 1High Science Co., Ltd
05 2Hospira, Inc.
06 1JILIN ASYMCHEM LABORATORIES CO LTD
07 2RANBAXY LABORATORIES LIMITED
08 1SUZHOU HOMESUN PHARMACEUTICAL CO LTD
09 2Sandoz B2B
10 1Savior Lifetec Corporation
11 2Unimark Remedies Limited
01 1IMIPENEM (STERILE BULK)
02 1IMIPENEM (STERILE)
03 1IMIPENEM AND CILASTATIN (STERILE BULK)
04 1IMIPENEM AND CILASTATIN FOR INJECTION STERILE BULK
05 1IMIPENEM AND CILASTATIN STERILE BLEND
06 1IMIPENEM CRUDE
07 1IMIPENEM CRUDE (INTERMEDIATE)
08 1IMIPENEM MONOHYDRATE (STERILE)
09 1IMIPENEM MONOHYDRATE STERILE
10 1IMIPENEM TECHNICAL DRUG SUBSTANCE INTERMEDIATE
11 3IMIPENEM USP (STERILE)
12 1IMIPENEN STERILE
13 1PNB-THIENAMYCIN IMINE
14 1THN-CYCLIC (IMIPENEM INTERMEDIATE)
01 1China
02 5India
03 2Italy
04 2Switzerland
05 2Taiwan
06 3U.S.A
07 1Blank
01 9Active
02 7Inactive
01 3Complete
02 13Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-23
Pay. Date : 2013-09-12
DMF Number : 21535
Submission : 2008-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21486
Submission : 2008-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23194
Submission : 2009-10-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31777
Submission : 2017-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38054
Submission : 2023-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20048
Submission : 2006-12-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-30
Pay. Date : 2013-04-30
DMF Number : 19937
Submission : 2006-11-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23796
Submission : 2010-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28296
Submission : 2014-05-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-04
Pay. Date : 2014-07-10
DMF Number : 28356
Submission : 2014-06-16
Status : Active
Type : II
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