01 1ALP Pharm
02 1Auro Peptides Limited
03 1MSN Laboratories
04 1Viatris
01 4PLECANATIDE
01 1China
02 2India
03 1U.S.A
01 4Active
01 3Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35439
Submission : 2020-12-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-14
Pay. Date : 2021-09-23
DMF Number : 36321
Submission : 2021-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-15
Pay. Date : 2020-08-12
DMF Number : 34049
Submission : 2019-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-14
Pay. Date : 2020-12-16
DMF Number : 34227
Submission : 2019-11-27
Status : Active
Type : II
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