01 3ACS DOBFAR SPA
02 1Auronext Pharma Private Limited
03 2Daewoong Pharmaceutical
04 2Hospira, Inc.
05 1Kyongbo Pharmaceutical Co., Ltd
06 2RANBAXY LABORATORIES LIMITED
07 1SUZHOU HOMESUN PHARMACEUTICAL CO LTD
08 1Sandoz B2B
09 1Savior Lifetec Corporation
10 2Shenzhen Haibin Pharmaceutical
11 1Sterile India Pvt. Ltd
12 3Sumitomo Pharma
13 2Unimark Remedies Limited
14 1Zhejiang Hisun Pharmaceutical
15 1Zhejiang Jiuzhou Pharmaceutical
16 2Zhuhai United Laboratories Co ., Ltd.
01 1CRUDE MEROPENEM
02 1MEROPENEM
03 1MEROPENEM (NON-STERILE)
04 1MEROPENEM (STERILE)
05 1MEROPENEM BULK BLEND
06 1MEROPENEM CRUDE NON-STERILE
07 1MEROPENEM FOR INJECTION
08 1MEROPENEM FOR INJECTION (STERILE BULK)
09 1MEROPENEM FOR INJECTION BULK STERILE
10 1MEROPENEM FOR INJECTION STERILE BULK
11 1MEROPENEM FOR INJECTION USP
12 2MEROPENEM STERILE
13 1MEROPENEM STERILE, BULK
14 2MEROPENEM TECHNICAL
15 1MEROPENEM TRIHYDRATE NON STERILE
16 1MEROPENEM TRIHYDRATE STERILE
17 1MEROPENEM TRIHYDRATE, STERILE
18 1MEROPENEM USP (STERILE)
19 1MEROPENEM, STERILE
20 1MEROPENEM/SODIUM CARBONATE
21 1Meropenem Technical
22 1Meropenem USP
23 1STERILE MEROPENEM
24 1STERILE MEROPENEM FOR INFECTION
01 7China
02 6India
03 3Italy
04 3Japan
05 3South Korea
06 1Switzerland
07 1Taiwan
08 2U.S.A
01 11Active
02 15Inactive
01 3Complete
02 23Blank
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 : 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 : 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 25869
Submission : 2012-03-31
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
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