01 1Celgene Corporation
02 1Concord Biotech
03 1MSN Laboratories
04 1Teva API
05 1Zhejiang Hisun Pharmaceutical
01 1FR901228
02 4ROMIDEPSIN
01 1China
02 2India
03 1Israel
04 1U.S.A
01 3Active
02 2Inactive
01 3Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12079
Submission : 1996-08-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-15
Pay. Date : 2013-10-25
DMF Number : 27399
Submission : 2013-11-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-15
Pay. Date : 2019-05-28
DMF Number : 33497
Submission : 2019-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-10
Pay. Date : 2013-08-16
DMF Number : 27400
Submission : 2013-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33235
Submission : 2018-09-29
Status : Inactive
Type : II
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