CHIESI USA INC Discontinued
FDA Approved Drugs

CHIESI USA INC Discontinued

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.

Discontinued
  • Total Records 12
  • Latest Approval Date Apr 20, 2018
  • Data Source FDA
  • First Approval Date Dec 21, 1988
All
25
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Unclassified
2
View
Discontinued
12
View
RX
11
View
Company Overview

Company

CHIESI USA INC Discontinued

Country

U.S.A

Website

Visit Website

Email

busdev@crtx.com

Social Profiles

Company Snapshot

CHIESI USA INC Discontinued

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 ( 12 records )
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20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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

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

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

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

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
12 total
  • Discontinued
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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Drug Name

CARDENE

Application Number

19488

Product Number

1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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