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

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01 5SANOFI AVENTIS US

02 3ACCORD HLTHCARE

03 2ACTAVIS

04 2ACTAVIS TOTOWA

05 2AM REGENT

06 2CHARTWELL MOLECULAR

07 2EUGIA PHARMA

08 2FRESENIUS KABI ONCOL

09 7FRESENIUS KABI USA

10 3GLAND

11 2GLAND PHARMA LTD

12 2HENGRUI PHARMA

13 2HOSPIRA INC

14 2HOSPIRA WORLDWIDE

15 2MEITHEAL

16 1MUSTAFA NEVSAT IIAC SANAYII A.S.

17 3MYLAN LABS LTD

18 2NORVIUM BIOSCIENCE

19 2NOVAST LABS

20 1PLIVA LACHEMA

21 5QILU PHARM HAINAN

22 6SANDOZ

23 5SUN PHARM

24 2TEVA PHARMS

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PharmaCompass

01

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AAPS 2024
Not Confirmed
  • 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 :

OXALIPLATIN

Brand Name : ELOXATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2002-08-09

Application Number : 21492

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Sanofi Company Banner

02

arrow
AAPS 2024
Not Confirmed
  • 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 :

OXALIPLATIN

Brand Name : ELOXATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2002-08-09

Application Number : 21492

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Sanofi Company Banner

03

arrow
AAPS 2024
Not Confirmed
  • 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 :

OXALIPLATIN

Brand Name : ELOXATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 50MG/10ML (5MG/ML)

Approval Date : 2005-01-31

Application Number : 21759

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Sanofi Company Banner

04

arrow
AAPS 2024
Not Confirmed
  • 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 :

OXALIPLATIN

Brand Name : ELOXATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 100MG/20ML (5MG/ML)

Approval Date : 2005-01-31

Application Number : 21759

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Sanofi Company Banner

05

arrow
AAPS 2024
Not Confirmed
  • 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 :

OXALIPLATIN

Brand Name : ELOXATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2006-11-17

Application Number : 21759

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Sanofi Company Banner

06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

OXALIPLATIN

Brand Name : OXALIPLATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 50MG/VIAL

Approval Date : 2012-08-08

Application Number : 78803

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

OXALIPLATIN

Brand Name : OXALIPLATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 100MG/VIAL

Approval Date : 2012-08-08

Application Number : 78803

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

OXALIPLATIN

Brand Name : OXALIPLATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 50MG/VIAL

Approval Date : 2009-08-07

Application Number : 78810

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

OXALIPLATIN

Brand Name : OXALIPLATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 50MG/10ML (5MG/ML)

Approval Date : 2009-08-07

Application Number : 22160

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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10

AAPS 2024
Not Confirmed
arrow
arrow
AAPS 2024
Not Confirmed

OXALIPLATIN

Brand Name : OXALIPLATIN

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 100MG/20ML (5MG/ML)

Approval Date : 2009-08-07

Application Number : 22160

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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