GE Healthcare Inc
FDA Approved Drugs

GE Healthcare Inc

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 6
  • Latest Approval Date Jun 29, 2026
  • Data Source FDA
  • First Approval Date Jan 14, 2011
Company Overview

Company

GE Healthcare Inc

Country

United Kingdom

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Company Snapshot

GE Healthcare Inc

Amersham Place Little Chalfont Buckinghamshire HP7 9NA

United Kingdom

www.gehealthcare.co.uk/ View on Map
FDA Approved Drug Records ( 6 records )
2011
14 Jan
RX Application: 22454

Drug Name

DATSCAN

Product Number

1

Dosage Form

-

Strength

5mCi/2.5ML (2mCi/ML)

Approval Date

2011-01-14

22454 / 1

Active Ingredient

IOFLUPANE I-123

Application Number

22454

Product Number

1

Dosage Form

-

Strength

5mCi/2.5ML (2mCi/ML)

Approval Date

2011-01-14

Regulatory Status

RX

2024
27 Sep
RX Application: 215168

Drug Name

FLYRCADO

Product Number

1

Dosage Form

-

Strength

5-55mCi/ML

Approval Date

2024-09-27

215168 / 1

Active Ingredient

FLURPIRIDAZ F-18

Application Number

215168

Product Number

1

Dosage Form

-

Strength

5-55mCi/ML

Approval Date

2024-09-27

Regulatory Status

RX

2026
29 Jun
RX Application: 215957

Drug Name

PIXXOSCAN

Product Number

1

Dosage Form

-

Strength

1.20944GM/2ML (604.72MG/ML)

Approval Date

2026-06-29

215957 / 1

Active Ingredient

GADOBUTROL

Application Number

215957

Product Number

1

Dosage Form

-

Strength

1.20944GM/2ML (604.72MG/ML)

Approval Date

2026-06-29

Regulatory Status

RX

2026
29 Jun
RX Application: 215957

Drug Name

PIXXOSCAN

Product Number

2

Dosage Form

-

Strength

4.5354GM/7.5ML (604.72MG/ML)

Approval Date

2026-06-29

215957 / 2

Active Ingredient

GADOBUTROL

Application Number

215957

Product Number

2

Dosage Form

-

Strength

4.5354GM/7.5ML (604.72MG/ML)

Approval Date

2026-06-29

Regulatory Status

RX

2026
29 Jun
RX Application: 215957

Drug Name

PIXXOSCAN

Product Number

3

Dosage Form

-

Strength

6.0472GM/10ML (604.72MG/ML)

Approval Date

2026-06-29

215957 / 3

Active Ingredient

GADOBUTROL

Application Number

215957

Product Number

3

Dosage Form

-

Strength

6.0472GM/10ML (604.72MG/ML)

Approval Date

2026-06-29

Regulatory Status

RX

2026
29 Jun
RX Application: 215957

Drug Name

PIXXOSCAN

Product Number

4

Dosage Form

-

Strength

9.0708GM/15ML (604.72MG/ML)

Approval Date

2026-06-29

215957 / 4

Active Ingredient

GADOBUTROL

Application Number

215957

Product Number

4

Dosage Form

-

Strength

9.0708GM/15ML (604.72MG/ML)

Approval Date

2026-06-29

Regulatory Status

RX

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Drug Status Breakdown
6 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

DATSCAN

Application Number

22454

Product Number

1

Active Ingredient

IOFLUPANE I-123

Dosage Form

-

Strength

5mCi/2.5ML (2mCi/ML)

FDA Approved Drug Data

Approved drug product information

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