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

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01 4SANOFI AVENTIS US

02 2DR REDDYS

03 5ACCORD HLTHCARE

04 2ACIC PHARMS

05 4ACTAVIS

06 3ALEMBIC

07 3AMNEAL

08 2APOTEX INC

09 4AVYXA HOLDINGS

10 3DFB ONCOLOGY LTD

11 3EUGIA PHARMA

12 3GLAND PHARMA LTD

13 4HENGRUI PHARMA

14 2HIKMA

15 7HOSPIRA INC

16 3MEITHEAL

17 4MYLAN LABS LTD

18 2NORVIUM BIOSCIENCE

19 3NOVAST LABS

20 4PFIZER LABS

21 3SANDOZ

22 6SHILPA

23 5SUN PHARM

24 2TEVA PHARMS USA

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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 :

DOCETAXEL

Brand Name : TAXOTERE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1996-05-14

Application Number : 20449

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Sanofi Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AP

DOCETAXEL

Brand Name : DOCETAXEL

Dosage Form : INJECTABLE;INJECTION

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

Approval Date : 2014-11-05

Application Number : 204193

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

03

  • 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 : AP

DOCETAXEL

Brand Name : TAXOTERE

Dosage Form : INJECTABLE;INJECTION

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

Approval Date : 2010-08-03

Application Number : 20449

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Sanofi Company Banner

04

  • 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 : AP

DOCETAXEL

Brand Name : TAXOTERE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 80MG/4ML (20MG/ML)

Approval Date : 2010-08-02

Application Number : 20449

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Sanofi Company Banner

05

  • 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 : AP

DOCETAXEL

Brand Name : TAXOTERE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 160MG/8ML (20MG/ML)

Approval Date : 2012-04-13

Application Number : 20449

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

Sanofi Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AP

DOCETAXEL

Brand Name : DOCETAXEL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 80MG/4ML (20MG/ML)

Approval Date : 2014-11-05

Application Number : 204193

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

Dr Reddy Company Banner

07

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DOCETAXEL

Brand Name : DOCETAXEL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 20MG/2ML (10MG/ML)

Approval Date : 2011-03-08

Application Number : 22234

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

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Not Confirmed

DOCETAXEL

Brand Name : DOCETAXEL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 80MG/8ML (10MG/ML)

Approval Date : 2011-03-08

Application Number : 22234

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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09

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Not Confirmed
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Not Confirmed

DOCETAXEL

Brand Name : DOCETAXEL

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 160MG/16ML (10MG/ML)

Approval Date : 2011-03-08

Application Number : 22234

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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10

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DOCETAXEL

Brand Name : DOCETAXEL

Dosage Form : INJECTABLE;INJECTION

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

Approval Date : 2016-06-23

Application Number : 22234

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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