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01 1GENZYME CORP

02 1SANOFI AVENTIS US

03 1ACTAVIS LLC

04 1ACTAVIS TOTOWA

05 1AREVA PHARMS

06 1CAPLIN ONE LABS

07 1EXTROVIS

08 2FRESENIUS KABI USA

09 1HIKMA

10 1HOSPIRA

11 1RISING

12 1SAGENT PHARMS INC

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : Yes

TE Code :

FLUDARABINE PHOSPHATE

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Dosage Strength : 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

RLD : No

TE Code :

FLUDARABINE PHOSPHATE

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 :

Sanofi Company Banner

03

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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

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04

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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

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05

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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

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06

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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

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07

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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

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08

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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 :

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09

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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

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10

CAPLIN ONE LABS

Country
ASCO GU
Not Confirmed
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CAPLIN ONE LABS

Country
arrow
ASCO GU
Not Confirmed

FLUDARABINE PHOSPHATE

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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