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Approved Drug Products containing Fludarabine listed in the FDA Orange Book. Original Data : FDA Website

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01 GENZYME CORP (1)

02 SANOFI AVENTIS US (1)

03 ACTAVIS LLC (1)

04 ACTAVIS TOTOWA (1)

05 AREVA PHARMS (1)

06 FRESENIUS KABI USA (2)

07 HIKMA (1)

08 HOSPIRA (1)

09 MYLAN LABS LTD (1)

10 RISING (1)

11 SAGENT PHARMS INC (1)

12 SANDOZ (1)

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01 INJECTABLE;INJECTION (12)

02 TABLET;ORAL (1)

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01 DISCN (7)

02 RX (6)

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01 FLUDARA (1)

02 FLUDARABINE PHOSPHATE (11)

03 OFORTA (1)

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01 No (11)

02 Yes (2)

URL Supplier Web Content
INJECTABLE;INJECTION
50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1991-04-18
20038
FLUDARA
DISCN
Yes
Sanofi Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET;ORAL
10MG
2008-12-18
22273
OFORTA
DISCN
No
Sanofi Company Banner

EMWA 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
INJECTABLE;INJECTION
50MG/VIAL
2009-02-11
78610
FLUDARABINE PHOSPHATE
RX
No
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INJECTABLE;INJECTION
50MG/2ML (25MG/ML)
2010-09-27
90724
FLUDARABINE PHOSPHATE
RX
No
AP1
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INJECTABLE;INJECTION
50MG/2ML (25MG/ML)
2007-10-15
78393
FLUDARABINE PHOSPHATE
RX
No
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INJECTABLE;INJECTION
50MG/VIAL
2007-10-15
78544
FLUDARABINE PHOSPHATE
RX
No
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INJECTABLE;INJECTION
50MG/VIAL
2003-08-28
76349
FLUDARABINE PHOSPHATE
RX
No
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INJECTABLE;INJECTION
50MG/VIAL
2007-04-06
77790
FLUDARABINE PHOSPHATE
DISCN
No
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INJECTABLE;INJECTION
50MG/2ML (25MG/ML)
2004-04-28
76661
FLUDARABINE PHOSPHATE
RX
No
AP1
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INJECTABLE;INJECTION
50MG/2ML (25MG/ML)
2007-09-21
22137
FLUDARABINE PHOSPHATE
DISCN
Yes
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