Alkermes Plc
FDA Approved Drugs

Alkermes 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 RX
  • Total Records 3
  • Latest Approval Date Apr 13, 2006
  • Data Source FDA
  • First Approval Date Dec 10, 1997
All
3
View
Discontinued
2
View
RX
1
View
Company Overview

Company

Alkermes Plc

Country

Ireland

Social Profiles

LinkedIn
Company Snapshot

Alkermes Plc

Connaught House, 1 Burlington Road, Dublin 4, Ireland

Ireland

www.alkermes.com/ financial@alkermes.com View on Map
FDA Approved Drug Records ( 3 records )
1998
22 Sep
Discontinued Application: 75041

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1998-09-22

75041 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75041

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1998-09-22

Regulatory Status

Discontinued

1997
10 Dec
Discontinued Application: 74879

Drug Name

KETOPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-12-10

74879 / 1

Active Ingredient

KETOPROFEN

Application Number

74879

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-12-10

Regulatory Status

Discontinued

2006
13 Apr
RX Application: 21897

Drug Name

VIVITROL

Product Number

1

Dosage Form

-

Strength

380MG/VIAL

Approval Date

2006-04-13

21897 / 1

Active Ingredient

NALTREXONE

Application Number

21897

Product Number

1

Dosage Form

-

Strength

380MG/VIAL

Approval Date

2006-04-13

Regulatory Status

RX

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  • FDA Approved Drugs Database
    3 View
Drug Status Breakdown
3 total
  • Discontinued
  • 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

ISOSORBIDE MONONITRATE

Application Number

75041

Product Number

1

Active Ingredient

ISOSORBIDE MONONITRATE

Dosage Form

-

Strength

60MG

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