Shionogi
FDA Approved Drugs

Shionogi

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 11
  • Latest Approval Date May 29, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
11
View
Discontinued
8
View
RX
3
View
Company Overview

Company

Shionogi

Country

Japan

Website

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Company Snapshot

Shionogi

1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045

Japan

www.shionogi.com/eu/en/ View on Map
FDA Approved Drug Records ( 11 records )
2007
12 Oct
Discontinued Application: 22106

Drug Name

DORIBAX

Product Number

1

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-10-12

22106 / 1

Active Ingredient

DORIPENEM

Application Number

22106

Product Number

1

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-10-12

Regulatory Status

Discontinued

2010
05 Oct
Discontinued Application: 22106

Drug Name

DORIBAX

Product Number

2

Dosage Form

-

Strength

250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-10-05

22106 / 2

Active Ingredient

DORIPENEM

Application Number

22106

Product Number

2

Dosage Form

-

Strength

250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2010-10-05

Regulatory Status

Discontinued

2019
14 Nov
RX Application: 209445

Drug Name

FETROJA

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2019-11-14

209445 / 1

Active Ingredient

CEFIDEROCOL SULFATE TOSYLATE

Application Number

209445

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2019-11-14

Regulatory Status

RX

2017
05 May
Discontinued Application: 209176

Drug Name

RADICAVA

Product Number

1

Dosage Form

-

Strength

30MG/100ML (0.3MG/ML)

Approval Date

2017-05-05

209176 / 1

Active Ingredient

EDARAVONE

Application Number

209176

Product Number

1

Dosage Form

-

Strength

30MG/100ML (0.3MG/ML)

Approval Date

2017-05-05

Regulatory Status

Discontinued

2018
15 Nov
Discontinued Application: 209176

Drug Name

RADICAVA

Product Number

2

Dosage Form

-

Strength

60MG/100ML (0.6MG/ML)

Approval Date

2018-11-15

209176 / 2

Active Ingredient

EDARAVONE

Application Number

209176

Product Number

2

Dosage Form

-

Strength

60MG/100ML (0.6MG/ML)

Approval Date

2018-11-15

Regulatory Status

Discontinued

2022
12 May
RX Application: 215446

Drug Name

RADICAVA ORS

Product Number

1

Dosage Form

-

Strength

105MG/5ML

Approval Date

2022-05-12

215446 / 1

Active Ingredient

EDARAVONE

Application Number

215446

Product Number

1

Dosage Form

-

Strength

105MG/5ML

Approval Date

2022-05-12

Regulatory Status

RX

2009
09 Apr
Discontinued Application: 22129

Drug Name

ULESFIA

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-04-09

22129 / 1

Active Ingredient

BENZYL ALCOHOL

Application Number

22129

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2009-04-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87307

Drug Name

UROBAK

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

87307 / 1

Active Ingredient

SULFAMETHOXAZOLE

Application Number

87307

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
28 Sep
Discontinued Application: 71816

Drug Name

UROPLUS DS

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1987-09-28

71816 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

71816

Product Number

1

Dosage Form

-

Strength

800MG;160MG

Approval Date

1987-09-28

Regulatory Status

Discontinued

1987
28 Sep
Discontinued Application: 71815

Drug Name

UROPLUS SS

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1987-09-28

71815 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

71815

Product Number

1

Dosage Form

-

Strength

400MG;80MG

Approval Date

1987-09-28

Regulatory Status

Discontinued

2026
29 May
RX Application: 220442

Drug Name

XOCOVA

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2026-05-29

220442 / 1

Active Ingredient

ENSITRELVIR

Application Number

220442

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2026-05-29

Regulatory Status

RX

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Drug Status Breakdown
11 total
  • Discontinued
  • RX
Official Source

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

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FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

DORIBAX

Application Number

22106

Product Number

1

Active Ingredient

DORIPENEM

Dosage Form

-

Strength

500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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