SHIRE PLC
FDA Approved Drugs

SHIRE PLC

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 Unclassified
  • Total Records 27
  • Latest Approval Date Dec 24, 1991
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
27
View
Unclassified
1
View
Discontinued
26
View
Company Overview

Company

SHIRE PLC

Country

Ireland

Website

Visit Website

Email

medinfoglobal@shire.com

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Company Snapshot

SHIRE PLC

No. 99854 22 Grenville Street St Helier Jersey JE4 8PX

Ireland

www.shire.com/ medinfoglobal@shire.com View on Map
FDA Approved Drug Records ( 27 records )
1986
01 Oct
Discontinued Application: 87628

Drug Name

ANOQUAN

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1986-10-01

87628 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

87628

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1986-10-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 7390

Drug Name

BANTHINE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

7390 / 1

Active Ingredient

METHANTHELINE BROMIDE

Application Number

7390

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84051

Drug Name

DEXTROSTAT

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

84051 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

84051

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84051

Drug Name

DEXTROSTAT

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

84051 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

84051

Product Number

2

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16913

Drug Name

DOPAR

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

16913 / 1

Active Ingredient

LEVODOPA

Application Number

16913

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16913

Drug Name

DOPAR

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

16913 / 2

Active Ingredient

LEVODOPA

Application Number

16913

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16913

Drug Name

DOPAR

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

16913 / 3

Active Ingredient

LEVODOPA

Application Number

16913

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16913

Drug Name

DOPAR

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

16913 / 4

Active Ingredient

LEVODOPA

Application Number

16913

Product Number

4

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16913

Drug Name

DOPAR

Product Number

5

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

16913 / 5

Active Ingredient

LEVODOPA

Application Number

16913

Product Number

5

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 125151

Drug Name

ELAPRASE

Product Number

1

Dosage Form

-

Strength

6MG/3ML

Approval Date

-

125151 / 1

Active Ingredient

IDURSULFASE

Application Number

125151

Product Number

1

Dosage Form

-

Strength

6MG/3ML

Approval Date

-

Regulatory Status

Unclassified

1990
19 Jun
Discontinued Application: 19753

Drug Name

ETHMOZINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1990-06-19

19753 / 1

Active Ingredient

MORICIZINE HYDROCHLORIDE

Application Number

19753

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1990-06-19

Regulatory Status

Discontinued

1990
19 Jun
Discontinued Application: 19753

Drug Name

ETHMOZINE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1990-06-19

19753 / 2

Active Ingredient

MORICIZINE HYDROCHLORIDE

Application Number

19753

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1990-06-19

Regulatory Status

Discontinued

1990
19 Jun
Discontinued Application: 19753

Drug Name

ETHMOZINE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1990-06-19

19753 / 3

Active Ingredient

MORICIZINE HYDROCHLORIDE

Application Number

19753

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1990-06-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5795

Drug Name

FURACIN

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

5795 / 1

Active Ingredient

NITROFURAZONE

Application Number

5795

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83789

Drug Name

FURACIN

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

83789 / 1

Active Ingredient

NITROFURAZONE

Application Number

83789

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83791

Drug Name

FURACIN

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

83791 / 1

Active Ingredient

NITROFURAZONE

Application Number

83791

Product Number

1

Dosage Form

-

Strength

0.2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11270

Drug Name

FUROXONE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

11270 / 2

Active Ingredient

FURAZOLIDONE

Application Number

11270

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11323

Drug Name

FUROXONE

Product Number

2

Dosage Form

-

Strength

50MG/15ML

Approval Date

1982-01-01

11323 / 2

Active Ingredient

FURAZOLIDONE

Application Number

11323

Product Number

2

Dosage Form

-

Strength

50MG/15ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8732

Drug Name

PRO-BANTHINE

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8732 / 2

Active Ingredient

PROPANTHELINE BROMIDE

Application Number

8732

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8732

Drug Name

PRO-BANTHINE

Product Number

3

Dosage Form

-

Strength

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8732 / 3

Active Ingredient

PROPANTHELINE BROMIDE

Application Number

8732

Product Number

3

Dosage Form

-

Strength

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12359

Drug Name

SALUTENSIN

Product Number

3

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

12359 / 3

Active Ingredient

HYDROFLUMETHIAZIDE; RESERPINE

Application Number

12359

Product Number

3

Dosage Form

-

Strength

50MG;0.125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12359

Drug Name

SALUTENSIN-DEMI

Product Number

4

Dosage Form

-

Strength

25MG;0.125MG

Approval Date

1982-01-01

12359 / 4

Active Ingredient

HYDROFLUMETHIAZIDE; RESERPINE

Application Number

12359

Product Number

4

Dosage Form

-

Strength

25MG;0.125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
24 Dec
Discontinued Application: 19836

Drug Name

SUPPRELIN

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

1991-12-24

19836 / 1

Active Ingredient

HISTRELIN ACETATE

Application Number

19836

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

1991-12-24

Regulatory Status

Discontinued

1991
24 Dec
Discontinued Application: 19836

Drug Name

SUPPRELIN

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1991-12-24

19836 / 2

Active Ingredient

HISTRELIN ACETATE

Application Number

19836

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1991-12-24

Regulatory Status

Discontinued

1991
24 Dec
Discontinued Application: 19836

Drug Name

SUPPRELIN

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1991-12-24

19836 / 3

Active Ingredient

HISTRELIN ACETATE

Application Number

19836

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1991-12-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50493

Drug Name

TOPICYCLINE

Product Number

1

Dosage Form

-

Strength

2.2MG/ML

Approval Date

1982-01-01

50493 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

50493

Product Number

1

Dosage Form

-

Strength

2.2MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12892

Drug Name

URACIL MUSTARD

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

12892 / 1

Active Ingredient

URACIL MUSTARD

Application Number

12892

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

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Drug Status Breakdown
27 total
  • 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

ANOQUAN

Application Number

87628

Product Number

1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Dosage Form

-

Strength

325MG;50MG;40MG

FDA Approved Drug Data

Approved drug product information

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