01 2Brenntag
02 1Global Calcium
03 1Guangzhou Tosun Pharmaceutical
04 1Hunan Warrant Chiral Pharmaceutical
05 3Jost Chemical
06 1Macco Organiques, Spol. s.r o
07 1Mallinckrodt Pharmaceuticals
08 2Tomita Pharmaceutical
01 2China
02 1Czech Republic
03 1India
04 1Ireland
05 2Japan
06 2Switzerland
07 3U.S.A
01 5Active
02 3Inactive
03 4Blank
01 1Valid
02 11Blank
01 1228MF10107
02 11Blank
01 12Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-15
Pay. Date : 2014-07-02
DMF Number : 17702
Submission : 2004-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33422
Submission : 2019-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33645
Submission : 2019-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29989
Submission : 2015-11-02
Status : Active
Type : II
Certificate Number : R1-CEP 2015-374 - Rev 00
Issue Date : 2022-03-18
Type : Chemical
Substance Number : 99
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-27
Pay. Date : 2023-12-27
DMF Number : 36916
Submission : 2022-09-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26466
Submission : 2012-09-21
Status : Inactive
Type : II
Registration Number : 228MF10107
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2016-06-06
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32924
Submission : 2018-10-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21560
Submission : 2008-04-22
Status : Inactive
Type : II
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