01 3ACS DOBFAR SPA
02 1BIOTIKA a.s.
03 1Bristol Myers Squibb
04 2CSPC Pharmaceutical Group
05 1CSPC Zhongrun Pharmaceutical Inner Mongolia
06 3Fermenta Biotech Limited
07 1Fresenius Kabi AB Brunna
08 4GSK
09 1Harbin Pharmaceutical Group Co., Ltd.
10 1Inner Mongolia Changsheng Pharmaceutical
11 2JIANGXI DONGFENG PHARMACEUTICAL LLC
12 1Meiji Seika Pharma
13 1North China Pharmaceutical Co., Ltd.
14 1Royal DSM
15 1SPIC Limited, Pharmaceuticals Division
16 2Sandoz B2B
17 1Shandong Lukang Pharmaceutical Co., Ltd
18 6Blank
01 1BUFFERED PENICILLIN G POTASSIUM STERILE
02 18PENICILLIN G POTASSIUM
03 1PENICILLIN G POTASSIUM (CRUDE)
04 1PENICILLIN G POTASSIUM (FIRST CRYSTAL)
05 1PENICILLIN G POTASSIUM (INDUSTRY GRADE)
06 1PENICILLIN G POTASSIUM (NON-STERILE)
07 4PENICILLIN G POTASSIUM CRUDE
08 1PENICILLIN G POTASSIUM FOR INJECTION, USP (STERILE BULK)
09 1PENICILLIN G POTASSIUM STERILE
10 1PENICILLIN G POTASSIUM STERILE AND PENICILLIN G POTASSIUM STERILE, BUFFERED
11 1PENICILLIN G POTASSIUM USP23
12 1PENICILLIN G POTASSIUM, NON-STERILE, TECHNICAL GRADE
13 1STERILE PENICILLIN G POTASSIUM BUFFERED
01 9China
02 4India
03 3Italy
04 1Japan
05 1Netherlands
06 1Slovakia
07 1Sweden
08 2Switzerland
09 1U.S.A
10 4United Kingdom
11 6Blank
01 9Active
02 24Inactive
01 1Complete
02 32Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-07
DMF Number : 15976
Submission : 2002-05-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32396
Submission : 2018-06-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25526
Submission : 2011-11-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34893
Submission : 2020-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12523
Submission : 1997-05-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12094
Submission : 1996-08-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10234
Submission : 1993-05-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13724
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13767
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13222
Submission : 1998-04-30
Status : Active
Type : II
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