Xellia Pharmaceuticals ApS RX
FDA Approved Drugs

Xellia Pharmaceuticals ApS RX

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
  • Total Records 8
  • Latest Approval Date Jun 02, 2021
  • Data Source FDA
  • First Approval Date Jan 15, 2014
All
15
View
Discontinued
7
View
RX
8
View
Company Overview

Company

Xellia Pharmaceuticals ApS RX

Country

Denmark

Website

Visit Website

Email

info.dk@xellia.com

Social Profiles

Company Snapshot

Xellia Pharmaceuticals ApS RX

Dalslandsgade 11, 2300 Copenhagen S

Denmark

www.xellia.com/ info.dk@xellia.com View on Map
FDA Approved Drug Records ( 8 records )
2015
29 May
RX Application: 205356

Drug Name

COLISTIMETHATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2015-05-29

205356 / 1

Active Ingredient

COLISTIMETHATE SODIUM

Application Number

205356

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2015-05-29

Regulatory Status

RX

2016
15 Jun
RX Application: 206005

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2016-06-15

206005 / 1

Active Ingredient

DAPTOMYCIN

Application Number

206005

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2016-06-15

Regulatory Status

RX

2021
02 Jun
RX Application: 211713

Drug Name

MICAFUNGIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2021-06-02

211713 / 1

Active Ingredient

MICAFUNGIN SODIUM

Application Number

211713

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2021-06-02

Regulatory Status

RX

2021
02 Jun
RX Application: 211713

Drug Name

MICAFUNGIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2021-06-02

211713 / 2

Active Ingredient

MICAFUNGIN SODIUM

Application Number

211713

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2021-06-02

Regulatory Status

RX

2014
15 Jan
RX Application: 202766

Drug Name

POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

2014-01-15

202766 / 1

Active Ingredient

POLYMYXIN B SULFATE

Application Number

202766

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

2014-01-15

Regulatory Status

RX

2014
16 Sep
RX Application: 205685

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL

Approval Date

2014-09-16

205685 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

205685

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL

Approval Date

2014-09-16

Regulatory Status

RX

2015
28 Dec
RX Application: 204125

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2015-12-28

204125 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

204125

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2015-12-28

Regulatory Status

RX

2015
28 Dec
RX Application: 204125

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2015-12-28

204125 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

204125

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2015-12-28

Regulatory Status

RX

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Drug Status Breakdown
8 total
  • RX
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

COLISTIMETHATE SODIUM

Application Number

205356

Product Number

1

Active Ingredient

COLISTIMETHATE SODIUM

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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