01 1Alembic Pharmaceuticals Limited
02 1Cambrex Corporation
03 1Centaur Pharmaceuticals
04 1F.I.S. Fabbrica Italiana Sintetici
05 1R L Fine Chem
06 1Raks Pharma
01 4India
02 1Italy
03 1U.S.A
01 3Active
02 3Blank
01 1Valid
02 5Blank
01 6Blank
01 6Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-18
Pay. Date : 2020-09-24
DMF Number : 35185
Submission : 2020-09-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-04
Pay. Date : 2021-09-20
DMF Number : 35606
Submission : 2021-03-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-24
Pay. Date : 2021-08-25
DMF Number : 35794
Submission : 2021-03-25
Status : Active
Type : II
Certificate Number : R1-CEP 2014-087 - Rev 01
Issue Date : 2023-04-05
Type : Chemical
Substance Number : 474
Status : Valid
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