01 1Aurobindo Pharma Limited
02 1Changzhou Pharmaceutical Factory
03 2Chiral Quest
04 1Crystal Pharmaceutical
05 1Curia
06 1Lee Pharma
07 1MSN Laboratories
08 1Optimus Pharma
09 2Blank
01 8UPADACITINIB
02 1UPADACITINIB HEMIHYDRATE
03 1UPADACITINIB INTERMEDIATE 1 - TERT-BUTYL (5-TOSYL-5H-PYRROLO[2,3-B]PYRAZIN-2-YL) CARBAMATE
04 1UPADACITINIB INTERMEDIATE 2 - (3R,4S)-BENZYL 3-(2-BROMOACETYL)-4-ETHYLPYRROLIDINE-1-CARBOXYLATE
01 4China
02 4India
03 1U.S.A
04 2Blank
01 11Active
01 4Complete
02 7Blank
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 : 37868
Submission : 2023-02-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37853
Submission : 2023-02-20
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
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40344
Submission : 2024-08-19
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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