01 2AMINO GmbH
02 3Ajinomoto Company
03 1Cambridge Isotope Laboratories
04 1Kyowa Hakko Bio
05 1Mitsubishi Tanabe Pharma
06 1SIGMA TAU
07 1SNJ Labs
08 1Sekisui Medical Co. Ltd
09 1Yoneyama Yakuhin Kogyo
01 1A-KETOANALOGUE TO LEUCINE CALCIUM SALT
02 8L-LEUCINE
03 1L-LEUCINE (U-13C6)
04 1L-LEUCINE DRUG SUBSTANCE
05 1L-LEUCINE FROM FERMENTATION
01 2Germany
02 1India
03 7Japan
04 2U.S.A
01 6Active
02 6Inactive
01 2Complete
02 10Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31556
Submission : 2017-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 21761
Submission : 2008-07-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31258
Submission : 2016-12-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3828
Submission : 1980-06-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21618
Submission : 2008-05-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2622
Submission : 1976-02-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1275
Submission : 1968-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7223
Submission : 1987-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2778
Submission : 1976-10-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38243
Submission : 2023-04-03
Status : Active
Type : II
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