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Approved Drug Products of Helsinn Advanced Synthesis listed in the FDA Orange Book. Original Data : FDA Website

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01 FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE (2)

02 INFIGRATINIB PHOSPHATE (2)

03 MECHLORETHAMINE HYDROCHLORIDE (1)

04 NETUPITANT; PALONOSETRON HYDROCHLORIDE (1)

05 PALONOSETRON HYDROCHLORIDE (3)

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01 CAPSULE;ORAL (4)

02 GEL;TOPICAL (1)

03 INJECTABLE;INTRAVENOUS (2)

04 POWDER;INTRAVENOUS (1)

05 SOLUTION;INTRAVENOUS (1)

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01 100MG (1)

02 25MG (1)

03 300MG;EQ 0.5MG BASE (1)

04 EQ 0.016% BASE (1)

05 EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

06 EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

07 EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** (1)

08 EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) (1)

09 EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL (1)

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01 DISCN (6)

02 RX (3)

URL Supplier Web Content
POWDER; INTRAVENOU...
EQ 235MG BASE/VIAL...
2018-04-19
210493
AKYNZEO
DISCN
Yes
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SOLUTION; INTRAVEN...
EQ 235MG BASE/20ML...
2020-05-27
210493
AKYNZEO
RX
Yes
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CAPSULE; ORAL
25MG
2021-05-28
214622
TRUSELTIQ
DISCN
Yes
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CAPSULE; ORAL
100MG
2021-05-28
214622
TRUSELTIQ
DISCN
Yes
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GEL; TOPICAL
EQ 0.016% BASE
2013-08-23
202317
VALCHLOR
RX
Yes
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CAPSULE; ORAL
300MG;EQ 0.5MG BAS...
2014-10-10
205718
AKYNZEO
RX
Yes
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INJECTABLE; INTRAV...
EQ 0.25MG BASE/5ML...
2003-07-25
21372
ALOXI
DISCN
Yes
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INJECTABLE; INTRAV...
EQ 0.075MG BASE/1....
2008-02-29
21372
ALOXI
DISCN
Yes
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CAPSULE; ORAL
EQ 0.5MG BASE **Fe...
2008-08-22
22233
ALOXI
DISCN
Yes
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