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01 12',3',5'-TRI-O-ACETYLURIDINE
02 12',3'-DIDEOXYCYTIDINE
03 12',3'-DIDEOXYINOSINE
04 1ACONIAZIDE
05 1AMBISOME, LIPOSOMAL AMPHOTERICIN B
06 1COBICISTAT ON SILICON DIOXIDE
07 1DOBUTAMINE HYDROCHLORIDE
08 1ELVITEGRAVIR
09 1FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION
10 1FK506LC AND PLACEBO
11 1LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211)
12 1LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L)
13 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDMONTON, ALBERTA, CANADA.
14 1MFG. METHODS AND PROPERTIES OF 2'-3'-DIDEOXYADENOSINE
15 1MURINE MONOCLONAL ANTIBODY (IMM-LL-2) TO B-CELL LYMPHOMA AND LEUKEMIA CELLS
16 1MURINE MONOCLONAL ANTIBODY (IMMU-31) TO ALPHA-FETOPROTEIN
17 1MURINE MONOCLONAL ANTIBODY AND F(AB)2 FRAGMENT (IMMU-14) TO CARCINOEMBRYONIC ANTIGEN (CEA)
18 1PMPA GEL
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01 7GILEAD SCIENCES INC
02 3IMMUNOMEDICS INC
03 8RAYLO CHEMICALS
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01 18U.S.A
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01 3Active
02 15Inactive
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01 18Blank
GDUFA
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DMF Number : 9517
Submission : 1992-01-31
Status : Inactive
Type : II
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DMF Number : 6805
Submission : 1987-01-28
Status : Inactive
Type : II
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DMF Number : 7680
Submission : 1988-09-23
Status : Inactive
Type : II
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DMF Number : 8724
Submission : 1990-09-07
Status : Inactive
Type : II
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DMF Number : 9564
Submission : 1992-03-06
Status : Active
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DMF Number : 25188
Submission : 2011-10-24
Status : Active
Type : II