GUERBET
FDA Approved Drugs

GUERBET

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 16
  • Latest Approval Date Sep 21, 2022
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
16
View
Discontinued
3
View
RX
13
View
Company Overview

Company

GUERBET

Country

France

Website

Visit Website

Email

customer.service-us(at)guerbet-group.com

Social Profiles

Company Snapshot

GUERBET

15 rue des Vanesses Zone Paris Nord II 93420 Villepinte

France

www.guerbet.com/ customer.service-us(at)guerbet-group.com View on Map
FDA Approved Drug Records ( 16 records )
2013
20 Mar
RX Application: 204781

Drug Name

DOTAREM

Product Number

1

Dosage Form

-

Strength

37.69GM/100ML (376.9MG/ML)

Approval Date

2013-03-20

204781 / 1

Active Ingredient

GADOTERATE MEGLUMINE

Application Number

204781

Product Number

1

Dosage Form

-

Strength

37.69GM/100ML (376.9MG/ML)

Approval Date

2013-03-20

Regulatory Status

RX

2013
20 Mar
RX Application: 204781

Drug Name

DOTAREM

Product Number

2

Dosage Form

-

Strength

3.769GM/10ML (376.9MG/ML)

Approval Date

2013-03-20

204781 / 2

Active Ingredient

GADOTERATE MEGLUMINE

Application Number

204781

Product Number

2

Dosage Form

-

Strength

3.769GM/10ML (376.9MG/ML)

Approval Date

2013-03-20

Regulatory Status

RX

2013
20 Mar
RX Application: 204781

Drug Name

DOTAREM

Product Number

3

Dosage Form

-

Strength

5.6535GM/15ML (376.9MG/ML)

Approval Date

2013-03-20

204781 / 3

Active Ingredient

GADOTERATE MEGLUMINE

Application Number

204781

Product Number

3

Dosage Form

-

Strength

5.6535GM/15ML (376.9MG/ML)

Approval Date

2013-03-20

Regulatory Status

RX

2013
20 Mar
RX Application: 204781

Drug Name

DOTAREM

Product Number

4

Dosage Form

-

Strength

7.538GM/20ML (376.9MG/ML)

Approval Date

2013-03-20

204781 / 4

Active Ingredient

GADOTERATE MEGLUMINE

Application Number

204781

Product Number

4

Dosage Form

-

Strength

7.538GM/20ML (376.9MG/ML)

Approval Date

2013-03-20

Regulatory Status

RX

2017
31 Mar
RX Application: 204781

Drug Name

DOTAREM

Product Number

5

Dosage Form

-

Strength

1.8845GM/5ML (376.9MG/ML)

Approval Date

2017-03-31

204781 / 5

Active Ingredient

GADOTERATE MEGLUMINE

Application Number

204781

Product Number

5

Dosage Form

-

Strength

1.8845GM/5ML (376.9MG/ML)

Approval Date

2017-03-31

Regulatory Status

RX

2022
21 Sep
RX Application: 216986

Drug Name

ELUCIREM

Product Number

1

Dosage Form

-

Strength

1.4553GM/3ML (485.1MG/ML)

Approval Date

2022-09-21

216986 / 1

Active Ingredient

GADOPICLENOL

Application Number

216986

Product Number

1

Dosage Form

-

Strength

1.4553GM/3ML (485.1MG/ML)

Approval Date

2022-09-21

Regulatory Status

RX

2022
21 Sep
RX Application: 216986

Drug Name

ELUCIREM

Product Number

2

Dosage Form

-

Strength

3.63825GM/7.5ML (485.1MG/ML)

Approval Date

2022-09-21

216986 / 2

Active Ingredient

GADOPICLENOL

Application Number

216986

Product Number

2

Dosage Form

-

Strength

3.63825GM/7.5ML (485.1MG/ML)

Approval Date

2022-09-21

Regulatory Status

RX

2022
21 Sep
RX Application: 216986

Drug Name

ELUCIREM

Product Number

3

Dosage Form

-

Strength

4.851GM/10ML (485.1MG/ML)

Approval Date

2022-09-21

216986 / 3

Active Ingredient

GADOPICLENOL

Application Number

216986

Product Number

3

Dosage Form

-

Strength

4.851GM/10ML (485.1MG/ML)

Approval Date

2022-09-21

Regulatory Status

RX

2022
21 Sep
RX Application: 216986

Drug Name

ELUCIREM

Product Number

4

Dosage Form

-

Strength

7.2765GM/15ML (485.1MG/ML)

Approval Date

2022-09-21

216986 / 4

Active Ingredient

GADOPICLENOL

Application Number

216986

Product Number

4

Dosage Form

-

Strength

7.2765GM/15ML (485.1MG/ML)

Approval Date

2022-09-21

Regulatory Status

RX

2022
21 Sep
RX Application: 216986

Drug Name

ELUCIREM

Product Number

5

Dosage Form

-

Strength

14.553GM/30ML (485.1MG/ML)

Approval Date

2022-09-21

216986 / 5

Active Ingredient

GADOPICLENOL

Application Number

216986

Product Number

5

Dosage Form

-

Strength

14.553GM/30ML (485.1MG/ML)

Approval Date

2022-09-21

Regulatory Status

RX

2022
21 Sep
RX Application: 216986

Drug Name

ELUCIREM

Product Number

6

Dosage Form

-

Strength

24.255GM/50ML (485.1MG/ML)

Approval Date

2022-09-21

216986 / 6

Active Ingredient

GADOPICLENOL

Application Number

216986

Product Number

6

Dosage Form

-

Strength

24.255GM/50ML (485.1MG/ML)

Approval Date

2022-09-21

Regulatory Status

RX

2022
21 Sep
RX Application: 216986

Drug Name

ELUCIREM

Product Number

7

Dosage Form

-

Strength

48.51GM/100ML (485.1MG/ML)

Approval Date

2022-09-21

216986 / 7

Active Ingredient

GADOPICLENOL

Application Number

216986

Product Number

7

Dosage Form

-

Strength

48.51GM/100ML (485.1MG/ML)

Approval Date

2022-09-21

Regulatory Status

RX

1985
26 Jul
Discontinued Application: 18905

Drug Name

HEXABRIX

Product Number

2

Dosage Form

-

Strength

39.3%;19.6%

Approval Date

1985-07-26

18905 / 2

Active Ingredient

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

Application Number

18905

Product Number

2

Dosage Form

-

Strength

39.3%;19.6%

Approval Date

1985-07-26

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 9190

Drug Name

LIPIODOL

Product Number

1

Dosage Form

-

Strength

EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)

Approval Date

1982-01-01

9190 / 1

Active Ingredient

ETHIODIZED OIL

Application Number

9190

Product Number

1

Dosage Form

-

Strength

EQ 4.8GM IODINE/10ML (EQ 480MG IODINE/ML)

Approval Date

1982-01-01

Regulatory Status

RX

1995
21 Dec
Discontinued Application: 20316

Drug Name

OXILAN-300

Product Number

1

Dosage Form

-

Strength

62%

Approval Date

1995-12-21

20316 / 1

Active Ingredient

IOXILAN

Application Number

20316

Product Number

1

Dosage Form

-

Strength

62%

Approval Date

1995-12-21

Regulatory Status

Discontinued

1995
21 Dec
Discontinued Application: 20316

Drug Name

OXILAN-350

Product Number

2

Dosage Form

-

Strength

73%

Approval Date

1995-12-21

20316 / 2

Active Ingredient

IOXILAN

Application Number

20316

Product Number

2

Dosage Form

-

Strength

73%

Approval Date

1995-12-21

Regulatory Status

Discontinued

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Drug Status Breakdown
16 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

DOTAREM

Application Number

204781

Product Number

1

Active Ingredient

GADOTERATE MEGLUMINE

Dosage Form

-

Strength

37.69GM/100ML (376.9MG/ML)

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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