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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Gilead Sciences to the U.S. FDA. Original Data : FDA Website

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01 2',3',5'-TRI-O-ACETYLURIDINE (1)

02 2',3'-DIDEOXYCYTIDINE (1)

03 2',3'-DIDEOXYINOSINE (1)

04 ACONIAZIDE (1)

05 AMBISOME, LIPOSOMAL AMPHOTERICIN B (1)

06 COBICISTAT ON SILICON DIOXIDE (1)

07 DOBUTAMINE HYDROCHLORIDE (1)

08 ELVITEGRAVIR (1)

09 FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION (1)

10 FK506LC AND PLACEBO (1)

11 INTERMEDIATE FOR ACA-147, 4-(2,2-DIMETHYLPROPYL)-N-HEXYLBENZENEMETHANAMINE HYDROCHLORIDE (1)

12 LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211) (1)

13 LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L) (1)

14 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN EDMONTON, ALBERTA, CANADA. (1)

15 MFG. METHODS AND PROPERTIES OF 2'-3'-DIDEOXYADENOSINE (1)

16 MURINE MONOCLONAL ANTIBODY (IMM-LL-2) TO B-CELL LYMPHOMA AND LEUKEMIA CELLS (1)

17 MURINE MONOCLONAL ANTIBODY (IMMU-31) TO ALPHA-FETOPROTEIN (1)

18 MURINE MONOCLONAL ANTIBODY AND F(AB)2 FRAGMENT (IMMU-14) TO CARCINOEMBRYONIC ANTIGEN (CEA) (1)

19 PMPA GEL (1)

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01 GILEAD SCIENCES INC (7)

02 IMMUNOMEDICS INC (3)

03 RAYLO CHEMICALS (9)

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01 U.S.A (19)

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01 Active (3)

02 Inactive (16)

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01 Blank (19)

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RAYLO CHEMICALS
Inactive
9517
N/A
1992-01-31
II
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RAYLO CHEMICALS
Inactive
6805
N/A
1987-01-28
II
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RAYLO CHEMICALS
Inactive
7680
N/A
1988-09-23
II
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RAYLO CHEMICALS
Inactive
8724
N/A
1990-09-07
II
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GILEAD SCIENCES INC
Active
9564
N/A
1992-03-06
II
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GILEAD SCIENCES INC
Active
25188
N/A
2011-10-24
II
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RAYLO CHEMICALS
Inactive
9024
N/A
1991-03-13
II
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GILEAD SCIENCES INC
Active
25187
N/A
2011-10-21
II
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GILEAD SCIENCES INC
Inactive
16237
N/A
2002-11-06
II
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GILEAD SCIENCES INC
Inactive
12688
N/A
1997-10-07
II
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