Eisai Inc
FDA Approved Drugs

Eisai Inc

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.

RX Discontinued Unclassified
  • Total Records 21
  • Latest Approval Date Apr 07, 2020
  • Data Source FDA
  • First Approval Date Dec 26, 1990
All
21
View
Unclassified
4
View
Discontinued
6
View
RX
11
View
Company Overview

Company

Eisai Inc

Country

U.S.A

Website

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Company Snapshot

Eisai Inc

200 Metro Blvd, Nutley, NJ 07110

U.S.A

us.eisai.com/ View on Map
FDA Approved Drug Records ( 21 records )
1996
25 Nov
RX Application: 20690

Drug Name

ARICEPT

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1996-11-25

20690 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

20690

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1996-11-25

Regulatory Status

RX

1996
25 Nov
RX Application: 20690

Drug Name

ARICEPT

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1996-11-25

20690 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

20690

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1996-11-25

Regulatory Status

RX

2004
18 Oct
Discontinued Application: 21719

Drug Name

ARICEPT

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2004-10-18

21719 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

21719

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2004-10-18

Regulatory Status

Discontinued

2010
23 Jul
RX Application: 22568

Drug Name

ARICEPT

Product Number

1

Dosage Form

-

Strength

23MG

Approval Date

2010-07-23

22568 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

22568

Product Number

1

Dosage Form

-

Strength

23MG

Approval Date

2010-07-23

Regulatory Status

RX

2004
18 Oct
Discontinued Application: 21720

Drug Name

ARICEPT ODT

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-10-18

21720 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

21720

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-10-18

Regulatory Status

Discontinued

2004
18 Oct
Discontinued Application: 21720

Drug Name

ARICEPT ODT

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-10-18

21720 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

21720

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-10-18

Regulatory Status

Discontinued

2008
14 Nov
Discontinued Application: 21911

Drug Name

BANZEL

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-11-14

21911 / 1

Active Ingredient

RUFINAMIDE

Application Number

21911

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-11-14

Regulatory Status

Discontinued

2008
14 Nov
RX Application: 21911

Drug Name

BANZEL

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2008-11-14

21911 / 2

Active Ingredient

RUFINAMIDE

Application Number

21911

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2008-11-14

Regulatory Status

RX

2008
14 Nov
RX Application: 21911

Drug Name

BANZEL

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2008-11-14

21911 / 3

Active Ingredient

RUFINAMIDE

Application Number

21911

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2008-11-14

Regulatory Status

RX

2011
03 Mar
RX Application: 201367

Drug Name

BANZEL

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2011-03-03

201367 / 1

Active Ingredient

RUFINAMIDE

Application Number

201367

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2011-03-03

Regulatory Status

RX

2020
07 Apr
RX Application: 212028

Drug Name

DAYVIGO

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-04-07

212028 / 1

Active Ingredient

LEMBOREXANT

Application Number

212028

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-04-07

Regulatory Status

RX

2020
07 Apr
RX Application: 212028

Drug Name

DAYVIGO

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-04-07

212028 / 2

Active Ingredient

LEMBOREXANT

Application Number

212028

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-04-07

Regulatory Status

RX

2010
15 Nov
RX Application: 201532

Drug Name

HALAVEN

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2010-11-15

201532 / 1

Active Ingredient

ERIBULIN MESYLATE

Application Number

201532

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2010-11-15

Regulatory Status

RX

1990
26 Dec
Discontinued Application: 19926

Drug Name

HEXALEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1990-12-26

19926 / 1

Active Ingredient

ALTRETAMINE

Application Number

19926

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1990-12-26

Regulatory Status

Discontinued

2015
13 Feb
RX Application: 206947

Drug Name

LENVIMA

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-02-13

206947 / 1

Active Ingredient

LENVATINIB MESYLATE

Application Number

206947

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-02-13

Regulatory Status

RX

2015
13 Feb
RX Application: 206947

Drug Name

LENVIMA

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-02-13

206947 / 2

Active Ingredient

LENVATINIB MESYLATE

Application Number

206947

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-02-13

Regulatory Status

RX

-
Unclassified Application: 761269

Drug Name

LEQEMBI

Product Number

1

Dosage Form

-

Strength

500MG/5ML

Approval Date

-

761269 / 1

Active Ingredient

LECANEMAB-IRMB

Application Number

761269

Product Number

1

Dosage Form

-

Strength

500MG/5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761269

Drug Name

LEQEMBI

Product Number

2

Dosage Form

-

Strength

200MG/2ML

Approval Date

-

761269 / 2

Active Ingredient

LECANEMAB-IRMB

Application Number

761269

Product Number

2

Dosage Form

-

Strength

200MG/2ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761375

Drug Name

LEQEMBI IQLIK

Product Number

3

Dosage Form

-

Strength

360MG/1.8ML(200MG/ML)

Approval Date

-

761375 / 3

Active Ingredient

LECANEMAB-IRMB

Application Number

761375

Product Number

3

Dosage Form

-

Strength

360MG/1.8ML(200MG/ML)

Approval Date

-

Regulatory Status

Unclassified

2008
12 Dec
Discontinued Application: 22244

Drug Name

LUSEDRA

Product Number

1

Dosage Form

-

Strength

1050MG/30ML (35MG/ML)

Approval Date

2008-12-12

22244 / 1

Active Ingredient

FOSPROPOFOL DISODIUM

Application Number

22244

Product Number

1

Dosage Form

-

Strength

1050MG/30ML (35MG/ML)

Approval Date

2008-12-12

Regulatory Status

Discontinued

-
Unclassified Application: 103767

Drug Name

ONTAK

Product Number

1

Dosage Form

-

Strength

150UG/ML

Approval Date

-

103767 / 1

Active Ingredient

DENILEUKIN DIFTITOX

Application Number

103767

Product Number

1

Dosage Form

-

Strength

150UG/ML

Approval Date

-

Regulatory Status

Unclassified

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Drug Status Breakdown
21 total
  • RX
  • 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

ARICEPT

Application Number

20690

Product Number

1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

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