01 1Avanos
02 1BioSpectra
03 1Cambridge Isotope Laboratories
04 1ISP Sutton Laboratories
05 1Merck Group
06 1PerkinElmer
07 1SAFC
01 113C UREA
02 1GERMALL II (DIAZOLIDINYL UREA)
03 1UREA
04 1UREA ACTIVE PHARMACEUTICAL INGREDIENT
05 1UREA-13 C
06 1[14C]-UREA
07 1[14C]-UREA, USP (PYTEST DRUG SUBSTANCE)
01 1Germany
02 6U.S.A
01 5Active
02 2Inactive
01 1Complete
02 6Blank
GDUFA
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DMF Number : 18942
Submission : 2005-11-08
Status : Active
Type : II
GDUFA
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DMF Number : 31669
Submission : 2017-04-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 11378
Submission : 1995-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 5519
Submission : 1984-09-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-24
Pay. Date : 2016-07-26
DMF Number : 29874
Submission : 2015-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10161
Submission : 1993-03-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11455
Submission : 1995-04-17
Status : Active
Type : II
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