01 1API Corporation
02 1Biocon
03 1Chongqing DaXin Pharmaceutical
04 1Concord Biotech
05 1Formosa Laboratories
06 1Hangzhou Zhongmei Huadong Pharmaceutical
07 1JIAOZUO JOINCARE BIOTECHNOLOGICAL CO LTD
08 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
09 1Livzon New North River Pharmaceutical
10 1Livzon Pharmaceutical Group
11 1Lunan Pharmaceutical
12 2Olon S.p.A
13 2Sandoz B2B
14 1Sterling Biotech
15 1Tocopharm Co. Limited
16 2Zhejiang Hisun Pharmaceutical
01 10China
02 3India
03 2Italy
04 1Japan
05 2Switzerland
06 1Taiwan
01 7Active
02 8Inactive
03 4Blank
01 1Valid
02 18Blank
01 19Blank
01 19Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15193
Submission : 2000-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26404
Submission : 2012-09-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20452
Submission : 2007-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32389
Submission : 2017-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21404
Submission : 2008-02-20
Status : Inactive
Type : II
NDC Package Code : 20076-0405
Start Marketing Date : 2018-12-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23061
Submission : 2009-08-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23065
Submission : 2009-08-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29920
Submission : 2015-10-08
Status : Inactive
Type : II
Certificate Number : CEP 2018-157 - Rev 02
Issue Date : 2024-02-09
Type : Chemical
Substance Number : 1700
Status : Valid
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