Chiesi Group
FDA Approved Drugs

Chiesi Group

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.

Unclassified RX Discontinued
  • Total Records 14
  • Latest Approval Date May 14, 2026
  • Data Source FDA
  • First Approval Date Dec 21, 2012
All
14
View
Unclassified
3
View
Discontinued
2
View
RX
9
View
Company Overview

Company

Chiesi Group

Country

Italy

Website

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Company Snapshot

Chiesi Group

26/A, Via Palermo (Main entrance: 1, Via Giacomo Chiesi) 43122 Parma

Italy

www.chiesi.com/en/ View on Map
FDA Approved Drug Records ( 14 records )
-
Unclassified Application: 761161

Drug Name

ELFABRIO

Product Number

1

Dosage Form

-

Strength

20MG/10ML

Approval Date

-

761161 / 1

Active Ingredient

PEGUNIGALSIDASE ALFA-IWXJ

Application Number

761161

Product Number

1

Dosage Form

-

Strength

20MG/10ML

Approval Date

-

Regulatory Status

Unclassified

2023
18 Dec
RX Application: 215064

Drug Name

FILSUVEZ

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2023-12-18

215064 / 1

Active Ingredient

BIRCH TRITERPENES

Application Number

215064

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2023-12-18

Regulatory Status

RX

2012
21 Dec
RX Application: 203858

Drug Name

JUXTAPID

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-21

203858 / 1

Active Ingredient

LOMITAPIDE MESYLATE

Application Number

203858

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-12-21

Regulatory Status

RX

2012
21 Dec
RX Application: 203858

Drug Name

JUXTAPID

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-21

203858 / 2

Active Ingredient

LOMITAPIDE MESYLATE

Application Number

203858

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-12-21

Regulatory Status

RX

2012
21 Dec
RX Application: 203858

Drug Name

JUXTAPID

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-12-21

203858 / 3

Active Ingredient

LOMITAPIDE MESYLATE

Application Number

203858

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-12-21

Regulatory Status

RX

2015
23 Apr
RX Application: 203858

Drug Name

JUXTAPID

Product Number

4

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-04-23

203858 / 4

Active Ingredient

LOMITAPIDE MESYLATE

Application Number

203858

Product Number

4

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-04-23

Regulatory Status

RX

2015
23 Apr
Discontinued Application: 203858

Drug Name

JUXTAPID

Product Number

5

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-04-23

203858 / 5

Active Ingredient

LOMITAPIDE MESYLATE

Application Number

203858

Product Number

5

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2015-04-23

Regulatory Status

Discontinued

2015
23 Apr
Discontinued Application: 203858

Drug Name

JUXTAPID

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2015-04-23

203858 / 6

Active Ingredient

LOMITAPIDE MESYLATE

Application Number

203858

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2015-04-23

Regulatory Status

Discontinued

2026
25 Feb
RX Application: 203858

Drug Name

JUXTAPID

Product Number

7

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2026-02-25

203858 / 7

Active Ingredient

LOMITAPIDE MESYLATE

Application Number

203858

Product Number

7

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2026-02-25

Regulatory Status

RX

-
Unclassified Application: 761278

Drug Name

LAMZEDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

761278 / 1

Active Ingredient

VELMANASE ALFA-TYCV

Application Number

761278

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125390

Drug Name

MYALEPT

Product Number

1

Dosage Form

-

Strength

11.3MG

Approval Date

-

125390 / 1

Active Ingredient

METRELEPTIN

Application Number

125390

Product Number

1

Dosage Form

-

Strength

11.3MG

Approval Date

-

Regulatory Status

Unclassified

2020
26 Jun
RX Application: 208232

Drug Name

MYCAPSSA

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-06-26

208232 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

208232

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-06-26

Regulatory Status

RX

2026
14 May
RX Application: 219622

Drug Name

TRIMBOW

Product Number

1

Dosage Form

-

Strength

0.086MG/INH;0.0049MG/INH;0.0106MG/INH

Approval Date

2026-05-14

219622 / 1

Active Ingredient

BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Application Number

219622

Product Number

1

Dosage Form

-

Strength

0.086MG/INH;0.0049MG/INH;0.0106MG/INH

Approval Date

2026-05-14

Regulatory Status

RX

2026
14 May
RX Application: 219622

Drug Name

TRIMBOW

Product Number

2

Dosage Form

-

Strength

0.172MG/INH;0.0049MG/INH;0.0106MG/INH

Approval Date

2026-05-14

219622 / 2

Active Ingredient

BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Application Number

219622

Product Number

2

Dosage Form

-

Strength

0.172MG/INH;0.0049MG/INH;0.0106MG/INH

Approval Date

2026-05-14

Regulatory Status

RX

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Drug Status Breakdown
14 total
  • Unclassified
  • 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

ELFABRIO

Application Number

761161

Product Number

1

Active Ingredient

PEGUNIGALSIDASE ALFA-IWXJ

Dosage Form

-

Strength

20MG/10ML

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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