Kyowa Kirin
FDA Approved Drugs

Kyowa Kirin

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.

Unclassified Discontinued RX
  • Total Records 5
  • Latest Approval Date Aug 27, 2019
  • Data Source FDA
  • First Approval Date May 29, 1997
All
5
View
Unclassified
2
View
Discontinued
1
View
RX
2
View
Company Overview

Company

Kyowa Kirin

Country

Japan

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Company Snapshot

Kyowa Kirin

Ohtemachi Building, 1-6-1 Ohtemachi,

Japan

www.kyowa-kirin.com View on Map
FDA Approved Drug Records ( 5 records )
-
Unclassified Application: 761068

Drug Name

CRYSVITA

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

-

761068 / 1

Active Ingredient

BUROSUMAB-TWZA

Application Number

761068

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

-

Regulatory Status

Unclassified

1997
29 May
Discontinued Application: 20497

Drug Name

FARESTON

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-29

20497 / 1

Active Ingredient

TOREMIFENE CITRATE

Application Number

20497

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-05-29

Regulatory Status

Discontinued

2019
27 Aug
RX Application: 22075

Drug Name

NOURIANZ

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-08-27

22075 / 1

Active Ingredient

ISTRADEFYLLINE

Application Number

22075

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-08-27

Regulatory Status

RX

2019
27 Aug
RX Application: 22075

Drug Name

NOURIANZ

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-08-27

22075 / 2

Active Ingredient

ISTRADEFYLLINE

Application Number

22075

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-08-27

Regulatory Status

RX

-
Unclassified Application: 761051

Drug Name

POTELIGEO

Product Number

1

Dosage Form

-

Strength

20MG/5ML

Approval Date

-

761051 / 1

Active Ingredient

MOGAMULIZUMAB-KPKC

Application Number

761051

Product Number

1

Dosage Form

-

Strength

20MG/5ML

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
5 total
  • Unclassified
  • 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

CRYSVITA

Application Number

761068

Product Number

1

Active Ingredient

BUROSUMAB-TWZA

Dosage Form

-

Strength

10MG/ML

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