01 1Alkermes Plc
02 2BioLife Solutions
03 1Gaylord Chemical Company, LLC
04 1Laboratorio Syntex S.A
05 1LifeCell
06 1Protide Pharmaceuticals
07 1SIGMA TAU
08 1Saintsun Pharma
09 1Showa Kako
10 1The Division of Cancer Treatment and Diagnosis
11 1Blank
01 1Argentina
02 1China
03 1India
04 1Ireland
05 1Japan
06 6U.S.A
07 1Blank
01 3Active
02 5Inactive
03 4Blank
01 2Valid
02 10Blank
01 1301MF10105
02 1302MF40040
03 1303MF40046
04 9Blank
01 12Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22739
Submission : 2009-05-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-06
Pay. Date : 2013-01-30
DMF Number : 12706
Submission : 1997-10-20
Status : Active
Type : II
Certificate Number : R1-CEP 2012-365 - Rev 00
Issue Date : 2019-02-25
Type : Chemical
Substance Number : 763
Status : Valid
Registration Number : 301MF10105
Registrant's Address : 106 Galeria Blvd Slidell, LA 70458, USA
Initial Date of Registration : 2019-12-10
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34909
Submission : 2020-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5236
Submission : 1984-02-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4138
Submission : 1981-04-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26197
Submission : 2012-08-16
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 804
Submission : 1964-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1067
Submission : 1967-06-29
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-062 - Rev 00
Issue Date : 2024-08-06
Type : Chemical
Substance Number : 763
Status : Valid
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