01 1AMINO GmbH
02 2Ajinomoto Company
03 1Kyowa Hakko Bio
04 2Mitsubishi Tanabe Pharma
05 1Nippon Kayaku
06 1SIGMA TAU
07 1SNJ Labs
01 1A-KETOANALOGUE TO ISOLEUCINE CALCIUM SALT
02 7L-ISOLEUCINE
03 1L-THREONINE, L-TRYTOPHAN & L-ISOLEUCINE
01 1Germany
02 1India
03 6Japan
04 1U.S.A
01 4Active
02 5Inactive
01 2Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-12
Pay. Date : 2017-04-17
DMF Number : 29143
Submission : 2015-02-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-05
DMF Number : 21991
Submission : 2008-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4041
Submission : 1980-10-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2623
Submission : 1976-02-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9422
Submission : 1991-11-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1250
Submission : 1968-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4822
Submission : 1982-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9991
Submission : 1992-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38242
Submission : 2023-04-03
Status : Active
Type : II
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