CHIESI USA INC
FDA Approved Drugs

CHIESI USA 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 Discontinued Unclassified
  • Total Records 25
  • Latest Approval Date May 19, 2020
  • Data Source FDA
  • First Approval Date Dec 21, 1988
All
25
View
Unclassified
2
View
Discontinued
12
View
RX
11
View
Company Overview

Company

CHIESI USA INC

Country

U.S.A

Website

Visit Website

Email

busdev@crtx.com

Social Profiles

Company Snapshot

CHIESI USA INC

175 Regency Woods Place, Suite 600, Cary, NC 27518

U.S.A

www.chiesiusa.com/ busdev@crtx.com View on Map
FDA Approved Drug Records ( 25 records )
2012
12 Oct
RX Application: 201820

Drug Name

BETHKIS

Product Number

1

Dosage Form

-

Strength

300MG/4ML

Approval Date

2012-10-12

201820 / 1

Active Ingredient

TOBRAMYCIN

Application Number

201820

Product Number

1

Dosage Form

-

Strength

300MG/4ML

Approval Date

2012-10-12

Regulatory Status

RX

1988
21 Dec
Discontinued Application: 19488

Drug Name

CARDENE

Product Number

1

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-12-21

19488 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

19488

Product Number

1

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-12-21

Regulatory Status

Discontinued

1988
21 Dec
Discontinued Application: 19488

Drug Name

CARDENE

Product Number

2

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-12-21

19488 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

19488

Product Number

2

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-12-21

Regulatory Status

Discontinued

1992
30 Jan
RX Application: 19734

Drug Name

CARDENE

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

1992-01-30

19734 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

19734

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

1992-01-30

Regulatory Status

RX

2008
07 Nov
RX Application: 19734

Drug Name

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2008-11-07

19734 / 4

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

19734

Product Number

4

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2008-11-07

Regulatory Status

RX

2008
31 Jul
RX Application: 19734

Drug Name

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2008-07-31

19734 / 3

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

19734

Product Number

3

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2008-07-31

Regulatory Status

RX

2008
31 Jul
RX Application: 19734

Drug Name

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2008-07-31

19734 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

19734

Product Number

2

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2008-07-31

Regulatory Status

RX

2008
07 Nov
Discontinued Application: 19734

Drug Name

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2008-11-07

19734 / 5

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

19734

Product Number

5

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2008-11-07

Regulatory Status

Discontinued

1992
21 Feb
Discontinued Application: 20005

Drug Name

CARDENE SR

Product Number

1

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-02-21

20005 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

20005

Product Number

1

Dosage Form

-

Strength

30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-02-21

Regulatory Status

Discontinued

1992
21 Feb
Discontinued Application: 20005

Drug Name

CARDENE SR

Product Number

2

Dosage Form

-

Strength

45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-02-21

20005 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

20005

Product Number

2

Dosage Form

-

Strength

45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-02-21

Regulatory Status

Discontinued

1992
21 Feb
Discontinued Application: 20005

Drug Name

CARDENE SR

Product Number

3

Dosage Form

-

Strength

60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-02-21

20005 / 3

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

20005

Product Number

3

Dosage Form

-

Strength

60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-02-21

Regulatory Status

Discontinued

2008
01 Aug
RX Application: 22156

Drug Name

CLEVIPREX

Product Number

1

Dosage Form

-

Strength

25MG/50ML (0.5MG/ML)

Approval Date

2008-08-01

22156 / 1

Active Ingredient

CLEVIDIPINE

Application Number

22156

Product Number

1

Dosage Form

-

Strength

25MG/50ML (0.5MG/ML)

Approval Date

2008-08-01

Regulatory Status

RX

2008
01 Aug
RX Application: 22156

Drug Name

CLEVIPREX

Product Number

2

Dosage Form

-

Strength

50MG/100ML (0.5MG/ML)

Approval Date

2008-08-01

22156 / 2

Active Ingredient

CLEVIDIPINE

Application Number

22156

Product Number

2

Dosage Form

-

Strength

50MG/100ML (0.5MG/ML)

Approval Date

2008-08-01

Regulatory Status

RX

2013
08 Nov
Discontinued Application: 22156

Drug Name

CLEVIPREX

Product Number

3

Dosage Form

-

Strength

125MG/250ML (0.5MG/ML)

Approval Date

2013-11-08

22156 / 3

Active Ingredient

CLEVIDIPINE

Application Number

22156

Product Number

3

Dosage Form

-

Strength

125MG/250ML (0.5MG/ML)

Approval Date

2013-11-08

Regulatory Status

Discontinued

-
Unclassified Application: 20744

Drug Name

CUROSURF

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

-

20744 / 1

Active Ingredient

PORACTANT ALFA

Application Number

20744

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

-

Regulatory Status

Unclassified

2011
14 Oct
Discontinued Application: 21825

Drug Name

FERRIPROX

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-10-14

21825 / 1

Active Ingredient

DEFERIPRONE

Application Number

21825

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-10-14

Regulatory Status

Discontinued

2019
25 Jul
RX Application: 21825

Drug Name

FERRIPROX

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-07-25

21825 / 2

Active Ingredient

DEFERIPRONE

Application Number

21825

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-07-25

Regulatory Status

RX

2015
09 Sep
RX Application: 208030

Drug Name

FERRIPROX

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2015-09-09

208030 / 1

Active Ingredient

DEFERIPRONE

Application Number

208030

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2015-09-09

Regulatory Status

RX

2018
20 Apr
Discontinued Application: 208030

Drug Name

FERRIPROX

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2018-04-20

208030 / 2

Active Ingredient

DEFERIPRONE

Application Number

208030

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2018-04-20

Regulatory Status

Discontinued

2020
19 May
RX Application: 212269

Drug Name

FERRIPROX

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2020-05-19

212269 / 1

Active Ingredient

DEFERIPRONE

Application Number

212269

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2020-05-19

Regulatory Status

RX

2015
22 Jun
RX Application: 204958

Drug Name

KENGREAL

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2015-06-22

204958 / 1

Active Ingredient

CANGRELOR

Application Number

204958

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2015-06-22

Regulatory Status

RX

-
Unclassified Application: 761092

Drug Name

REVCOVI

Product Number

1

Dosage Form

-

Strength

1.6MG/ML

Approval Date

-

761092 / 1

Active Ingredient

ELAPEGADEMASE-LVLR

Application Number

761092

Product Number

1

Dosage Form

-

Strength

1.6MG/ML

Approval Date

-

Regulatory Status

Unclassified

1996
09 Dec
Discontinued Application: 20471

Drug Name

ZYFLO

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1996-12-09

20471 / 1

Active Ingredient

ZILEUTON

Application Number

20471

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1996-12-09

Regulatory Status

Discontinued

1996
09 Dec
Discontinued Application: 20471

Drug Name

ZYFLO

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

1996-12-09

20471 / 3

Active Ingredient

ZILEUTON

Application Number

20471

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

1996-12-09

Regulatory Status

Discontinued

2007
30 May
Discontinued Application: 22052

Drug Name

ZYFLO CR

Product Number

1

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-05-30

22052 / 1

Active Ingredient

ZILEUTON

Application Number

22052

Product Number

1

Dosage Form

-

Strength

600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-05-30

Regulatory Status

Discontinued

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Drug Status Breakdown
25 total
  • RX
  • Discontinued
  • Unclassified
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

BETHKIS

Application Number

201820

Product Number

1

Active Ingredient

TOBRAMYCIN

Dosage Form

-

Strength

300MG/4ML

FDA Approved Drug Data

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