01 1Auro Peptides Limited
02 1Chengdu Shengnuo Biopharm
03 1CordenPharma
04 2Hybio Pharmaceutical
05 2MSN Laboratories
06 2PolyPeptide Group
07 1Sun Pharmaceutical Industries Limited
08 1Teva API
09 1Blank
01 7LINACLOTIDE
02 1LINACLOTIDE (NON-STERILE BULK DRUG SUBSTANCE)
03 2LINACLOTIDE DRUG SUBSTANCE
04 1LINACLOTIDE NON-STERILE DRUG SUBSTANCE
05 1LINACLOTIDE [ROUTE CODE LE]
01 3China
02 1Germany
03 4India
04 1Israel
05 2Switzerland
06 1Blank
01 11Active
02 1Inactive
01 6Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-09-18
DMF Number : 29708
Submission : 2015-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-30
Pay. Date : 2023-09-19
DMF Number : 35812
Submission : 2021-04-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24992
Submission : 2011-05-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-01
Pay. Date : 2023-09-25
DMF Number : 37370
Submission : 2022-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32314
Submission : 2017-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2017-02-28
DMF Number : 31351
Submission : 2017-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25025
Submission : 2011-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25021
Submission : 2011-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-23
Pay. Date : 2016-02-23
DMF Number : 30266
Submission : 2016-11-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-25
Pay. Date : 2016-02-12
DMF Number : 30274
Submission : 2016-03-10
Status : Active
Type : II
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