Recordati RX
FDA Approved Drugs

Recordati 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 15
  • Latest Approval Date Aug 19, 2020
  • Data Source FDA
  • First Approval Date Jan 30, 1991
All
21
View
Discontinued
6
View
RX
15
View
Company Overview

Company

Recordati RX

Country

Italy

Website

Visit Website

Email

svil@recordati.it

Social Profiles

LinkedIn
Company Snapshot

Recordati RX

Via Matteo Civitali, 1 20148 Milan

Italy

www.recordati.com/en/ svil@recordati.it View on Map
FDA Approved Drug Records ( 15 records )
2010
18 Mar
RX Application: 22562

Drug Name

CARBAGLU

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2010-03-18

22562 / 1

Active Ingredient

CARGLUMIC ACID

Application Number

22562

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2010-03-18

Regulatory Status

RX

1991
30 Jan
RX Application: 19998

Drug Name

CHEMET

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1991-01-30

19998 / 2

Active Ingredient

SUCCIMER

Application Number

19998

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1991-01-30

Regulatory Status

RX

1996
25 Oct
RX Application: 20576

Drug Name

CYSTADANE

Product Number

1

Dosage Form

-

Strength

1GM/SCOOPFUL

Approval Date

1996-10-25

20576 / 1

Active Ingredient

BETAINE

Application Number

20576

Product Number

1

Dosage Form

-

Strength

1GM/SCOOPFUL

Approval Date

1996-10-25

Regulatory Status

RX

2020
19 Aug
RX Application: 211302

Drug Name

CYSTADROPS

Product Number

1

Dosage Form

-

Strength

EQ 0.37% BASE

Approval Date

2020-08-19

211302 / 1

Active Ingredient

CYSTEAMINE HYDROCHLORIDE

Application Number

211302

Product Number

1

Dosage Form

-

Strength

EQ 0.37% BASE

Approval Date

2020-08-19

Regulatory Status

RX

2020
06 Mar
RX Application: 212801

Drug Name

ISTURISA

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2020-03-06

212801 / 1

Active Ingredient

OSILODROSTAT PHOSPHATE

Application Number

212801

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2020-03-06

Regulatory Status

RX

2020
06 Mar
RX Application: 212801

Drug Name

ISTURISA

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2020-03-06

212801 / 2

Active Ingredient

OSILODROSTAT PHOSPHATE

Application Number

212801

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2020-03-06

Regulatory Status

RX

2006
13 Apr
RX Application: 21903

Drug Name

NEOPROFEN

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

Approval Date

2006-04-13

21903 / 1

Active Ingredient

IBUPROFEN LYSINE

Application Number

21903

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

Approval Date

2006-04-13

Regulatory Status

RX

2012
14 Dec
RX Application: 200677

Drug Name

SIGNIFOR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2012-12-14

200677 / 1

Active Ingredient

PASIREOTIDE DIASPARTATE

Application Number

200677

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2012-12-14

Regulatory Status

RX

2012
14 Dec
RX Application: 200677

Drug Name

SIGNIFOR

Product Number

2

Dosage Form

-

Strength

EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)

Approval Date

2012-12-14

200677 / 2

Active Ingredient

PASIREOTIDE DIASPARTATE

Application Number

200677

Product Number

2

Dosage Form

-

Strength

EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)

Approval Date

2012-12-14

Regulatory Status

RX

2012
14 Dec
RX Application: 200677

Drug Name

SIGNIFOR

Product Number

3

Dosage Form

-

Strength

EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)

Approval Date

2012-12-14

200677 / 3

Active Ingredient

PASIREOTIDE DIASPARTATE

Application Number

200677

Product Number

3

Dosage Form

-

Strength

EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)

Approval Date

2012-12-14

Regulatory Status

RX

2014
15 Dec
RX Application: 203255

Drug Name

SIGNIFOR LAR KIT

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2014-12-15

203255 / 1

Active Ingredient

PASIREOTIDE PAMOATE

Application Number

203255

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2014-12-15

Regulatory Status

RX

2014
15 Dec
RX Application: 203255

Drug Name

SIGNIFOR LAR KIT

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2014-12-15

203255 / 2

Active Ingredient

PASIREOTIDE PAMOATE

Application Number

203255

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2014-12-15

Regulatory Status

RX

2014
15 Dec
RX Application: 203255

Drug Name

SIGNIFOR LAR KIT

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE/VIAL

Approval Date

2014-12-15

203255 / 3

Active Ingredient

PASIREOTIDE PAMOATE

Application Number

203255

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE/VIAL

Approval Date

2014-12-15

Regulatory Status

RX

2018
29 Jun
RX Application: 203255

Drug Name

SIGNIFOR LAR KIT

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

2018-06-29

203255 / 4

Active Ingredient

PASIREOTIDE PAMOATE

Application Number

203255

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

2018-06-29

Regulatory Status

RX

2018
29 Jun
RX Application: 203255

Drug Name

SIGNIFOR LAR KIT

Product Number

5

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

2018-06-29

203255 / 5

Active Ingredient

PASIREOTIDE PAMOATE

Application Number

203255

Product Number

5

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

2018-06-29

Regulatory Status

RX

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Drug Status Breakdown
15 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

CARBAGLU

Application Number

22562

Product Number

1

Active Ingredient

CARGLUMIC ACID

Dosage Form

-

Strength

200MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

Structured Database

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