01 1Alkermes Plc
02 1Gaylord Chemical Company, LLC
03 1Laboratorio Syntex S.A
04 1LifeCell
05 1Protide Pharmaceuticals
06 1SIGMA TAU
07 1Showa Kako
08 1The Division of Cancer Treatment and Diagnosis
01 12-8CELLsius™ + DMSO
02 3DIMETHYL SULFOXIDE
03 1DIMETHYL SULFOXIDE (DMSO), USP GRADE
04 1DIMETHYL SULFOXIDE (DMSO-P)
05 1DMSO 55%W/V DEXTRAN-40 5%W/V SOLUTION
06 1MICROSPHERE DILUENT
01 1Argentina
02 1India
03 1Ireland
04 1Japan
05 4U.S.A
01 3Active
02 5Inactive
01 1Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22739
Submission : 2009-05-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2013-01-30
DMF Number : 12706
Submission : 1997-10-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1067
Submission : 1967-06-29
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 : 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 : 804
Submission : 1964-01-22
Status : Inactive
Type : II
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