01 1Glenmark Life Sciences
02 1HONOUR LAB LTD
03 1Intas Pharmaceuticals
04 1MSN Laboratories
05 1Sterling Pharma Solutions
06 1Teva API
07 1Zydus Lifesciences
01 5DIROXIMEL FUMARATE
02 1DIROXIMEL FUMARATE DRUG SUBSTANCE
03 1DIROXIMEL FUMATATE
01 5India
02 1Israel
03 1United Kingdom
01 7Active
01 4Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35785
Submission : 2021-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-10
Pay. Date : 2021-09-02
DMF Number : 36019
Submission : 2021-09-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-20
Pay. Date : 2020-03-11
DMF Number : 34677
Submission : 2020-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34718
Submission : 2020-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32977
Submission : 2018-10-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-22
Pay. Date : 2019-04-01
DMF Number : 33752
Submission : 2019-04-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-28
Pay. Date : 2023-02-15
DMF Number : 35373
Submission : 2020-11-26
Status : Active
Type : II
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