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
18 1Teva API
19 1Teva Pharmaceutical Industries
20 1Viatris
21 1Zhejiang Shenzhou Pharmaceutical
22 2Blank
01 4China
02 8India
03 1Ireland
04 2Israel
05 5Italy
06 1Japan
07 1Spain
08 2U.S.A
09 2Blank
01 6Active
02 14Inactive
03 6Blank
01 3Valid
02 2Withdrawn by Holder
03 21Blank
01 1224MF10109
02 1228MF10204
03 24Blank
01 1WC-0015
02 1WC-0031
03 1WC-0066
04 1WC-0091
05 1WC-0127
06 1WC-0199
07 1WC-0201
08 19Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2013-08-01
DMF Number : 26747
Submission : 2012-12-20
Status : Active
Type : II
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
NDC Package Code : 65977-0082
Start Marketing Date : 2000-05-26
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 : 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Status : Withdrawn by Holder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 : 18976
Submission : 2007-04-08
Status : Inactive
Type : II
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