01 1ACS DOBFAR SPA
02 3Aurobindo Pharma Limited
03 1CSPC Pharmaceutical Group
04 1Eumedica Pharmaceuticals
05 1Farmastur 2010, S.L.
06 1Fresenius Kabi Anti-Infectives
07 1Grand Health Industrial Co Ltd
08 1Hengdian Group
09 2Istituto Biochimico Italiano Giovanni Lorenzini SpA
10 1JIANGXI DONGFENG PHARMACEUTICAL LLC
11 1Jiangxi Fushine Pharmaceutical Co. Ltd
12 2Kyongbo Pharmaceutical Co., Ltd
13 3Mustafa Nevzat Ilac Sanayi A S
14 2North China Pharmaceutical Co., Ltd.
15 1Qilu Pharmaceutical
16 1Qilu Tianhe Pharmaceutical Co., Ltd.
17 1Rajasthan Antibiotics
18 1Reyoung pharmaceutical
19 1Sandoz B2B
20 1Shin Poong Pharm Co Ltd
21 1Sichuan Renan Pharmaceutical
22 1Tecoland Corporation
23 1Vaishali Pharma Ltd
24 1Zhejiang Hisun Pharmaceutical
25 1Zhuhai United Laboratories Co ., Ltd.
01 13China
02 5India
03 4Italy
04 3South Korea
05 1Spain
06 2Switzerland
07 3Turkey
08 1U.S.A
01 7Active
02 7Inactive
03 18Blank
01 3Valid
02 29Blank
01 1218MF10710
02 1219MF10293
03 1220MF10060
04 1226MF10212
05 1227MF10104
06 1228MF10054
07 1229MF10066
08 1230MF10001
09 1303MF10153
10 23Blank
01 1WC-0121
02 31Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-11
Pay. Date : 2015-05-26
DMF Number : 29231
Submission : 2015-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14974
Submission : 2000-08-04
Status : Active
Type : II
Registration Number : 220MF10060
Registrant's Address : Poligono Industrial de Silvota, parcelas 22B-23 E-33192 Silvota, Llanera-Asturias (Spain)
Initial Date of Registration : 2008-02-25
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-23
Pay. Date : 2020-05-18
DMF Number : 34192
Submission : 2020-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23769
Submission : 2010-05-03
Status : Inactive
Type : II
Registrant Name : Korea Chorus Co., Ltd.
Registration Date : 2013-05-22
Registration Number : 20130207-150-I-192-05(4)
Manufacturer Name : Zhuhai United Laboratories Co., Ltd.
Manufacturer Address : Sanzao Science & Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong. 519040, PR China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16587
Submission : 2003-05-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17560
Submission : 2004-05-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22261
Submission : 2008-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17512
Submission : 2004-07-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16532
Submission : 2003-04-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17189
Submission : 2004-03-09
Status : Inactive
Type : II
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