01 1Aurobindo Pharma Limited
02 1Changzhou Pharmaceutical Factory
03 1Crystal Pharmaceutical
04 1Curia
05 1Lee Pharma
06 1MSN Laboratories
07 1Optimus Pharma
08 1Sichuan Gowell Pharmaceutical
09 1Blank
01 8UPADACITINIB
02 1UPADACITINIB HEMIHYDRATE
01 3China
02 4India
03 1U.S.A
04 1Blank
01 9Active
01 4Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-24
Pay. Date : 2023-02-21
DMF Number : 38095
Submission : 2023-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40355
Submission : 2024-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38427
Submission : 2023-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-16
Pay. Date : 2022-06-15
DMF Number : 37149
Submission : 2022-06-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39581
Submission : 2024-03-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-17
Pay. Date : 2023-04-25
DMF Number : 38153
Submission : 2023-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38051
Submission : 2023-02-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40344
Submission : 2024-08-19
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2023-07-05
Pay. Date : 2023-05-15
DMF Number : 38344
Submission : 2023-05-20
Status : Active
Type : II
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