01 1ANSTO HEALTH
02 1Allozymes
03 1BIOSYN ARZNEIMITTEL GMBH
04 1CURIUM US LLC
05 1Geltec Group
06 2IRE Elit
07 1Mallinckrodt Pharmaceuticals
08 1Quality Chemicals
09 1TopChem Pharmaceuticals
10 1Valaji PharmaChem
01 1Australia
02 2Belgium
03 1Germany
04 1India
05 2Ireland
06 1Singapore
07 1Spain
08 2U.S.A
01 5Active
02 6Blank
01 1Valid
02 10Blank
01 11Blank
01 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22872
Submission : 2009-06-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12103
Submission : 1996-08-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30679
Submission : 2017-01-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9191
Submission : 1991-06-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34024
Submission : 2019-08-29
Status : Active
Type : II
Certificate Number : CEP 2019-031 - Rev 02
Issue Date : 2024-09-10
Type : Chemical
Substance Number : 1565
Status : Valid
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