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

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01 DR REDDYS (2)

02 ACCORD HLTHCARE (1)

03 AKORN INC (1)

04 AVET LIFESCIENCES (2)

05 AVYXA PHARMA (2)

06 BAXTER HLTHCARE CORP (1)

07 CHARTWELL RX (1)

08 CIPLA (1)

09 EUGIA PHARMA (1)

10 FRESENIUS KABI USA (3)

11 HELSINN HLTHCARE (6)

12 HIKMA (1)

13 HOSPIRA (2)

14 MYLAN INSTITUTIONAL (1)

15 NANJING KING-FRIEND (1)

16 NOVAST LABS (1)

17 QILU PHARM HAINAN (2)

18 SAGENT PHARMS INC (2)

19 SANDOZ (1)

20 TEVA PHARMS USA (2)

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01 CAPSULE;ORAL (2)

02 INJECTABLE;INJECTION (1)

03 INJECTABLE;INTRAVENOUS (25)

04 POWDER;INTRAVENOUS (1)

05 SOLUTION;INTRAVENOUS (5)

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01 DISCN (15)

02 RX (18)

03 Blank (1)

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01 AKYNZEO (3)

02 ALOXI (3)

03 PALONOSETRON HYDROCHLORIDE (28)

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01 No (26)

02 Yes (7)

03 Blank (1)

INJECTABLE;INTRAVENOUS
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
2016-04-21
201533
PALONOSETRON HYDROCHLO...
DISCN
No
INJECTABLE;INTRAVENOUS
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
2016-04-21
201533
PALONOSETRON HYDROCHLO...
RX
No
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INJECTABLE;INTRAVENOUS
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
2021-06-29
202951
PALONOSETRON HYDROCHLO...
RX
No
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INJECTABLE;INTRAVENOUS
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
2021-06-29
202951
PALONOSETRON HYDROCHLO...
RX
No
AP
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INJECTABLE;INTRAVENOUS
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2003-07-25
21372
ALOXI
DISCN
Yes
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INJECTABLE;INTRAVENOUS
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-02-29
21372
ALOXI
DISCN
Yes
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CAPSULE;ORAL
EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
2008-08-22
22233
ALOXI
DISCN
Yes
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INJECTABLE;INTRAVENOUS
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
2015-10-13
202521
PALONOSETRON HYDROCHLO...
RX
No
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INJECTABLE;INTRAVENOUS
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
2018-03-23
90713
PALONOSETRON HYDROCHLO...
RX
No
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INJECTABLE;INTRAVENOUS
EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
2018-03-23
90713
PALONOSETRON HYDROCHLO...
DISCN
No
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