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

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01 SANOFI AVENTIS US (4)

02 DR REDDYS (2)

03 SUN PHARM (5)

04 ACCORD HLTHCARE (5)

05 ACIC PHARMS (2)

06 ACTAVIS (4)

07 ALEMBIC (3)

08 AMNEAL (3)

09 APOTEX INC (2)

10 AVYXA HOLDINGS (4)

11 DFB ONCOLOGY LTD (3)

12 EUGIA PHARMA (3)

13 GLAND PHARMA LTD (3)

14 HENGRUI PHARMA (4)

15 HIKMA (2)

16 HOSPIRA INC (7)

17 MEITHEAL (3)

18 MYLAN LABS LTD (6)

19 NOVAST LABS (3)

20 PFIZER LABS (4)

21 SANDOZ (3)

22 SHILPA (6)

23 TEVA PHARMS USA (2)

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01 INJECTABLE;INJECTION (80)

02 SOLUTION;INTRAVENOUS (3)

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01 DISCN (24)

02 RX (58)

03 Blank (1)

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01 DOCEFREZ (2)

02 DOCETAXEL (77)

03 TAXOTERE (4)

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01 No (58)

02 Yes (24)

03 Blank (1)

URL Supplier Web Content
INJECTABLE;INJECTION
40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1996-05-14
20449
TAXOTERE
DISCN
Yes
Sanofi Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
INJECTABLE;INJECTION
20MG/ML (20MG/ML)
2010-08-03
20449
TAXOTERE
RX
Yes
AP
Sanofi Company Banner

EMWA 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
INJECTABLE;INJECTION
80MG/4ML (20MG/ML)
2010-08-02
20449
TAXOTERE
RX
Yes
AP
Sanofi Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
INJECTABLE;INJECTION
160MG/8ML (20MG/ML)
2012-04-13
20449
TAXOTERE
RX
Yes
AP
Sanofi Company Banner

EMWA 2024

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
INJECTABLE;INJECTION
20MG/VIAL
2011-05-03
22534
DOCEFREZ
DISCN
Yes
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INJECTABLE;INJECTION
80MG/VIAL
2011-05-03
22534
DOCEFREZ
DISCN
Yes
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INJECTABLE;INJECTION
20MG/ML (20MG/ML)
2019-01-08
22534
DOCETAXEL
RX
No
AP
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INJECTABLE;INJECTION
80MG/4ML (20MG/ML)
2019-01-08
22534
DOCETAXEL
RX
No
AP
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