01 3ACS DOBFAR SPA
02 1Aurobindo Pharma Limited
03 1Auronext Pharma Private Limited
04 2Daewoong Pharmaceutical
05 3Hospira, Inc.
06 1Kyongbo Pharmaceutical Co., Ltd
07 2RANBAXY LABORATORIES LIMITED
08 1SUZHOU HOMESUN PHARMACEUTICAL CO LTD
09 1Sandoz B2B
10 1Savior Lifetec Corporation
11 3Shenzhen Haibin Pharmaceutical Co., Ltd.
12 1Sterile India Pvt. Ltd
13 3Sumitomo Pharma
14 2Unimark Remedies Limited
15 1Zhejiang Hisun Pharmaceutical
16 1Zhejiang Jiuzhou Pharmaceutical
17 2Zhuhai United Laboratories Co ., Ltd.
01 1CRUDE MEROPENEM
02 1MEROPENEM
03 2MEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)
04 1MEROPENEM (NON-STERILE)
05 1MEROPENEM (STERILE)
06 1MEROPENEM BULK BLEND
07 1MEROPENEM CRUDE NON-STERILE
08 1MEROPENEM FOR INJECTION
09 1MEROPENEM FOR INJECTION (STERILE BULK)
10 1MEROPENEM FOR INJECTION BULK STERILE
11 1MEROPENEM FOR INJECTION STERILE BULK
12 1MEROPENEM FOR INJECTION USP
13 2MEROPENEM STERILE
14 1MEROPENEM STERILE, BULK
15 2MEROPENEM TECHNICAL
16 1MEROPENEM TRIHYDRATE NON STERILE
17 1MEROPENEM TRIHYDRATE STERILE
18 1MEROPENEM TRIHYDRATE, STERILE
19 1MEROPENEM USP (STERILE)
20 1MEROPENEM, STERILE
21 1MEROPENEM/SODIUM CARBONATE
22 1MPEP (MEROPENEM INTERMEDIATE)
23 1Meropenem Technical
24 1Meropenem USP
25 1STERILE MEROPENEM
26 1STERILE MEROPENEM FOR INFECTION
01 8China
02 7India
03 3Italy
04 3Japan
05 3South Korea
06 1Switzerland
07 1Taiwan
08 3U.S.A
01 12Active
02 17Inactive
01 3Complete
02 26Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30489
Submission : 2016-06-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30488
Submission : 2016-07-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2017-07-06
DMF Number : 22503
Submission : 2009-02-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-25
Pay. Date : 2013-06-17
DMF Number : 27192
Submission : 2013-06-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21061
Submission : 2007-11-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23524
Submission : 2010-02-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29985
Submission : 2016-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23276
Submission : 2009-11-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-20
Pay. Date : 2014-07-20
DMF Number : 28279
Submission : 2014-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25869
Submission : 2012-03-31
Status : Active
Type : II
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