01 1AMINO GmbH
02 2Ajinomoto Company
03 1Daiichi Sankyo
04 1Mitsubishi Tanabe Pharma
05 1SIGMA TAU
06 1SNJ Labs
07 1UQUIFA
08 1Blank
01 12-ISOPROPYL-4-(N-METHYL) AMINOMETHYLTHIAZOYLCARBONYL-(L)-VALINE
02 1A-KETOANALOGUE TO VALINE CALCIUM SALT
03 7L-VALINE
01 1Germany
02 1India
03 4Japan
04 1Spain
05 1U.S.A
06 1Blank
01 4Active
02 5Inactive
01 2Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31561
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29141
Submission : 2015-02-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12720
Submission : 1997-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6933
Submission : 1987-04-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1253
Submission : 1968-10-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2765
Submission : 1976-10-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38246
Submission : 2023-04-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11670
Submission : 1995-09-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7454
Submission : 1988-04-19
Status : Inactive
Type : II
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