Helsinn Advanced Synthesis
FDA Approved Drugs

Helsinn Advanced Synthesis

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued
  • Total Records 9
  • Latest Approval Date May 28, 2021
  • Data Source FDA
  • First Approval Date Jul 25, 2003
All
9
View
Discontinued
6
View
RX
3
View
Company Overview

Company

Helsinn Advanced Synthesis

Country

Switzerland

Website

Visit Website

Email

manufacturing@helsinn.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Helsinn Advanced Synthesis

Via Industria 246710 Biasca – Switzerland

Switzerland

helsinn.com/ manufacturing@helsinn.com View on Map
FDA Approved Drug Records ( 9 records )
2014
10 Oct
RX Application: 205718

Drug Name

AKYNZEO

Product Number

1

Dosage Form

-

Strength

300MG;EQ 0.5MG BASE

Approval Date

2014-10-10

205718 / 1

Active Ingredient

NETUPITANT; PALONOSETRON HYDROCHLORIDE

Application Number

205718

Product Number

1

Dosage Form

-

Strength

300MG;EQ 0.5MG BASE

Approval Date

2014-10-10

Regulatory Status

RX

2018
19 Apr
Discontinued Application: 210493

Drug Name

AKYNZEO

Product Number

1

Dosage Form

-

Strength

EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

Approval Date

2018-04-19

210493 / 1

Active Ingredient

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Application Number

210493

Product Number

1

Dosage Form

-

Strength

EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

Approval Date

2018-04-19

Regulatory Status

Discontinued

2020
27 May
RX Application: 210493

Drug Name

AKYNZEO

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2020-05-27

210493 / 2

Active Ingredient

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

Application Number

210493

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2020-05-27

Regulatory Status

RX

2003
25 Jul
Discontinued Application: 21372

Drug Name

ALOXI

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-07-25

21372 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

21372

Product Number

1

Dosage Form

-

Strength

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**

Approval Date

2003-07-25

Regulatory Status

Discontinued

2008
29 Feb
Discontinued Application: 21372

Drug Name

ALOXI

Product Number

2

Dosage Form

-

Strength

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**

Approval Date

2008-02-29

21372 / 2

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

21372

Product Number

2

Dosage Form

-

Strength

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**

Approval Date

2008-02-29

Regulatory Status

Discontinued

2008
22 Aug
Discontinued Application: 22233

Drug Name

ALOXI

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-08-22

22233 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

22233

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2008-08-22

Regulatory Status

Discontinued

2021
28 May
Discontinued Application: 214622

Drug Name

TRUSELTIQ

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-05-28

214622 / 1

Active Ingredient

INFIGRATINIB PHOSPHATE

Application Number

214622

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-05-28

Regulatory Status

Discontinued

2021
28 May
Discontinued Application: 214622

Drug Name

TRUSELTIQ

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2021-05-28

214622 / 2

Active Ingredient

INFIGRATINIB PHOSPHATE

Application Number

214622

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2021-05-28

Regulatory Status

Discontinued

2013
23 Aug
RX Application: 202317

Drug Name

VALCHLOR

Product Number

1

Dosage Form

-

Strength

EQ 0.016% BASE

Approval Date

2013-08-23

202317 / 1

Active Ingredient

MECHLORETHAMINE HYDROCHLORIDE

Application Number

202317

Product Number

1

Dosage Form

-

Strength

EQ 0.016% BASE

Approval Date

2013-08-23

Regulatory Status

RX

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Drug Status Breakdown
9 total
  • RX
  • Discontinued
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

AKYNZEO

Application Number

205718

Product Number

1

Active Ingredient

NETUPITANT; PALONOSETRON HYDROCHLORIDE

Dosage Form

-

Strength

300MG;EQ 0.5MG BASE

FDA Approved Drug Data

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