01 1Chongqing Carelife Pharmaceutical
02 1Hetero Drugs
03 2MSN Laboratories
04 1Zhejiang Huayi Pharmaceutical Co., Ltd.
01 3REGORAFENIB
02 1REGORAFENIB MONOHYDRATE USP
03 1REGORAFENIB [ROUTE CODE "RZ"]
01 2China
02 3India
01 5Active
01 3Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-14
Pay. Date : 2023-05-08
DMF Number : 38197
Submission : 2023-04-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-05-02
DMF Number : 30490
Submission : 2016-05-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36838
Submission : 2022-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-21
Pay. Date : 2015-11-06
DMF Number : 29870
Submission : 2015-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39898
Submission : 2024-04-27
Status : Active
Type : II
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