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01 1Fermion Oy
02 1Cambrex Corporation
03 1Glenmark Life Sciences
04 1HONOUR LAB LTD
05 1Maithri Drugs
06 1Olon S.p.A
07 1Shionogi
08 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 8OSPEMIFENE
01 1China
02 1Finland
03 3India
04 1Italy
05 1Japan
06 1U.S.A
01 8Active
01 2Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 25541
Submission : 2011-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31163
Submission : 2018-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30574
Submission : 2016-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-07
Pay. Date : 2016-09-07
DMF Number : 30858
Submission : 2016-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38660
Submission : 2023-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-09-22
DMF Number : 29720
Submission : 2015-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35877
Submission : 2021-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30474
Submission : 2016-06-13
Status : Active
Type : II
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