Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1GENZYME CORP
02 1SANOFI AVENTIS US
03 1ACTAVIS LLC
04 1ACTAVIS TOTOWA
05 1AREVA PHARMS
06 2FRESENIUS KABI USA
07 1HIKMA
08 1HOSPIRA
09 2RISING
10 1SAGENT PHARMS INC
11 1SANDOZ
01 12INJECTABLE;INJECTION
02 1TABLET;ORAL
01 7DISCN
02 6RX
01 1FLUDARA
02 11FLUDARABINE PHOSPHATE
03 1OFORTA
01 11No
02 2Yes
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : Yes
TE Code :
Brand Name : FLUDARA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1991-04-18
Application Number : 20038
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD : No
TE Code :
Brand Name : OFORTA
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2008-12-18
Application Number : 22273
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/VIAL
Approval Date : 2009-02-11
Application Number : 78610
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP1
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/2ML (25MG/ML)
Approval Date : 2010-09-27
Application Number : 90724
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1
RLD : No
TE Code : AP1
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/2ML (25MG/ML)
Approval Date : 2007-10-15
Application Number : 78393
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1
RLD : No
TE Code : AP
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/VIAL
Approval Date : 2007-10-15
Application Number : 78544
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/VIAL
Approval Date : 2003-08-28
Application Number : 76349
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/VIAL
Approval Date : 2007-04-06
Application Number : 77790
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP1
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/2ML (25MG/ML)
Approval Date : 2004-04-28
Application Number : 76661
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1
RLD : Yes
TE Code :
Brand Name : FLUDARABINE PHOSPHATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 2007-09-21
Application Number : 22137
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
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