01 1API Corporation
02 1Actavis Inc
03 1Arch Pharmalabs
04 1Chemi SpA
05 1Curequest Lifescience
06 1Divis Laboratories
07 2Erregierre SpA
08 1Esteve Quimica
09 1Hengdian Group
10 1Hetero Drugs
11 2Ipca Laboratories
12 1Jiangsu Zhongdan Chemical
13 1Lupin Ltd
14 1Napp Technologies
15 2Recordati
16 1Solara Active Pharma Sciences
17 1Southwest Synthetic Pharmaceutical
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20 1Viatris
21 1Zhejiang Shenzhou Pharmaceutical
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01 4China
02 8India
03 1Ireland
04 2Israel
05 5Italy
06 1Japan
07 1Spain
08 2U.S.A
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01 6Active
02 14Inactive
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03 21Blank
01 1224MF10109
02 1228MF10204
03 24Blank
01 1WC-0015
02 1WC-0031
03 1WC-0066
04 1WC-0091
05 1WC-0127
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07 1WC-0201
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18212
Submission : 2005-03-28
Status : Active
Type : II
Certificate Number : R1-CEP 2006-092 - Rev 02
Issue Date : 2017-09-25
Type : Chemical
Substance Number : 1350
Status : Withdrawn by Holder
Date of Issue : 2019-06-03
Valid Till : 2022-06-02
Written Confirmation Number : WC-0015
Address of the Firm :
NDC Package Code : 65015-632
Start Marketing Date : 2015-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-08
Pay. Date : 2013-05-03
DMF Number : 18581
Submission : 2005-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13105
Submission : 1998-07-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15491
Submission : 2001-06-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14174
Submission : 1999-06-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14804
Submission : 2000-03-23
Status : Inactive
Type : II
Registrant Name : Chodang Pharmaceutical Industry Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-2-C-57-01
Manufacturer Name : ZHEJIANG SHENZHOU Pharmaceutical Co., Ltd
Manufacturer Address : No.14 Chuancheng Nan road 317300 Xianju, Zhejiang
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 11984
Submission : 1996-06-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12445
Submission : 1997-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21467
Submission : 2008-03-24
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-10
Written Confirmation Number : WC-0201
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18976
Submission : 2007-04-08
Status : Inactive
Type : II
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