Ipsen
FDA Approved Drugs

Ipsen

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 14
  • Latest Approval Date Jun 10, 2024
  • Data Source FDA
  • First Approval Date Aug 30, 2007
Company Overview

Company

Ipsen

Country

France

Website

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Company Snapshot

Ipsen

65 Quai Georges Gorse, 92100 Boulogne-Billancourt

France

www.ipsen.com/france/ View on Map
FDA Approved Drug Records ( 14 records )
2021
20 Jul
RX Application: 215498

Drug Name

BYLVAY

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

2021-07-20

215498 / 1

Active Ingredient

ODEVIXIBAT

Application Number

215498

Product Number

1

Dosage Form

-

Strength

0.2MG

Approval Date

2021-07-20

Regulatory Status

RX

2021
20 Jul
RX Application: 215498

Drug Name

BYLVAY

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2021-07-20

215498 / 2

Active Ingredient

ODEVIXIBAT

Application Number

215498

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2021-07-20

Regulatory Status

RX

2021
20 Jul
RX Application: 215498

Drug Name

BYLVAY

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2021-07-20

215498 / 3

Active Ingredient

ODEVIXIBAT

Application Number

215498

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2021-07-20

Regulatory Status

RX

2021
20 Jul
RX Application: 215498

Drug Name

BYLVAY

Product Number

4

Dosage Form

-

Strength

1.2MG

Approval Date

2021-07-20

215498 / 4

Active Ingredient

ODEVIXIBAT

Application Number

215498

Product Number

4

Dosage Form

-

Strength

1.2MG

Approval Date

2021-07-20

Regulatory Status

RX

2024
10 Jun
RX Application: 218860

Drug Name

IQIRVO

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2024-06-10

218860 / 1

Active Ingredient

ELAFIBRANOR

Application Number

218860

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2024-06-10

Regulatory Status

RX

2015
22 Oct
RX Application: 207793

Drug Name

ONIVYDE

Product Number

1

Dosage Form

-

Strength

EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

Approval Date

2015-10-22

207793 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

207793

Product Number

1

Dosage Form

-

Strength

EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)

Approval Date

2015-10-22

Regulatory Status

RX

2023
16 Aug
RX Application: 215559

Drug Name

SOHONOS

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-08-16

215559 / 1

Active Ingredient

PALOVAROTENE

Application Number

215559

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-08-16

Regulatory Status

RX

2023
16 Aug
RX Application: 215559

Drug Name

SOHONOS

Product Number

2

Dosage Form

-

Strength

1.5MG

Approval Date

2023-08-16

215559 / 2

Active Ingredient

PALOVAROTENE

Application Number

215559

Product Number

2

Dosage Form

-

Strength

1.5MG

Approval Date

2023-08-16

Regulatory Status

RX

2023
16 Aug
RX Application: 215559

Drug Name

SOHONOS

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2023-08-16

215559 / 3

Active Ingredient

PALOVAROTENE

Application Number

215559

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2023-08-16

Regulatory Status

RX

2023
16 Aug
RX Application: 215559

Drug Name

SOHONOS

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2023-08-16

215559 / 4

Active Ingredient

PALOVAROTENE

Application Number

215559

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2023-08-16

Regulatory Status

RX

2023
16 Aug
RX Application: 215559

Drug Name

SOHONOS

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2023-08-16

215559 / 5

Active Ingredient

PALOVAROTENE

Application Number

215559

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2023-08-16

Regulatory Status

RX

2007
30 Aug
RX Application: 22074

Drug Name

SOMATULINE DEPOT

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Approval Date

2007-08-30

22074 / 1

Active Ingredient

LANREOTIDE ACETATE

Application Number

22074

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Approval Date

2007-08-30

Regulatory Status

RX

2007
30 Aug
RX Application: 22074

Drug Name

SOMATULINE DEPOT

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

Approval Date

2007-08-30

22074 / 2

Active Ingredient

LANREOTIDE ACETATE

Application Number

22074

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

Approval Date

2007-08-30

Regulatory Status

RX

2007
30 Aug
RX Application: 22074

Drug Name

SOMATULINE DEPOT

Product Number

3

Dosage Form

-

Strength

EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

Approval Date

2007-08-30

22074 / 3

Active Ingredient

LANREOTIDE ACETATE

Application Number

22074

Product Number

3

Dosage Form

-

Strength

EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

Approval Date

2007-08-30

Regulatory Status

RX

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Drug Status Breakdown
14 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

BYLVAY

Application Number

215498

Product Number

1

Active Ingredient

ODEVIXIBAT

Dosage Form

-

Strength

0.2MG

FDA Approved Drug Data

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