01 1Alkem Laboratories
02 1Aurobindo Pharma Limited
03 1Glenmark Life Sciences
04 1Hetero Drugs
05 1Hikma Pharmaceuticals
06 1Unichem Laboratories Limited
01 5SOLRIAMFETOL HYDROCHLORIDE
02 1Solriamfetol Hydrochloride
01 5India
02 1United Kingdom
01 6Active
01 6Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-15
Pay. Date : 2023-02-03
DMF Number : 36951
Submission : 2022-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-28
Pay. Date : 2023-01-09
DMF Number : 37929
Submission : 2023-01-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-12-16
Pay. Date : 2022-11-14
DMF Number : 34741
Submission : 2020-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-05-16
Pay. Date : 2023-04-12
DMF Number : 38280
Submission : 2023-04-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-04
Pay. Date : 2022-12-19
DMF Number : 37548
Submission : 2022-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-16
Pay. Date : 2023-01-25
DMF Number : 36949
Submission : 2022-03-30
Status : Active
Type : II
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