01 1Archimica
02 3Bristol Myers Squibb
03 1CHEMSPEC CHEMICALS PVT LTD
04 1Fermenta Biotech Limited
05 2Olon S.p.A
06 1Qilu Tianhe Pharmaceutical Co., Ltd.
01 1HYDREA
02 5HYDROXYUREA
03 1HYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO)
04 1HYDROXYUREA LYOPHILIZED POWDER
05 1HYDROXYUREA USP (NON-STERILE BULK)
01 1China
02 2India
03 3Italy
04 3U.S.A
01 4Active
02 5Inactive
01 3Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-13
Pay. Date : 2019-02-08
DMF Number : 12754
Submission : 1997-11-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2452
Submission : 1975-05-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2259
Submission : 1974-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8361
Submission : 1989-12-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16458
Submission : 2003-02-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2258
Submission : 1974-04-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-26
Pay. Date : 2022-05-31
DMF Number : 37146
Submission : 2022-06-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11899
Submission : 1996-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-13
Pay. Date : 2012-12-13
DMF Number : 20615
Submission : 2007-06-15
Status : Active
Type : II
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