Otsuka Chemical Co Ltd RX
FDA Approved Drugs

Otsuka Chemical Co Ltd RX

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
  • Total Records 21
  • Latest Approval Date Apr 27, 2023
  • Data Source FDA
  • First Approval Date Nov 15, 2002
All
41
View
Discontinued
20
View
RX
21
View
Company Overview

Company

Otsuka Chemical Co Ltd RX

Country

Japan

Website

Visit Website

Email

yuichiro-shibata@otsukac.co.jp

Social Profiles

Company Snapshot

Otsuka Chemical Co Ltd RX

3-2-27, Ote-Dori, Chuo-Ku, Osaka, 540-0021

Japan

www.otsukac.co.jp:443/ yuichiro-shibata@otsukac.co.jp View on Map
FDA Approved Drug Records ( 21 records )
2002
15 Nov
RX Application: 21436

Drug Name

ABILIFY

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-11-15

21436 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

21436

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-11-15

Regulatory Status

RX

2002
15 Nov
RX Application: 21436

Drug Name

ABILIFY

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2002-11-15

21436 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

21436

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2002-11-15

Regulatory Status

RX

2002
15 Nov
RX Application: 21436

Drug Name

ABILIFY

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2002-11-15

21436 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

21436

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2002-11-15

Regulatory Status

RX

2002
15 Nov
RX Application: 21436

Drug Name

ABILIFY

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2002-11-15

21436 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

21436

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2002-11-15

Regulatory Status

RX

2002
15 Nov
RX Application: 21436

Drug Name

ABILIFY

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2002-11-15

21436 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

21436

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2002-11-15

Regulatory Status

RX

2002
15 Nov
RX Application: 21436

Drug Name

ABILIFY

Product Number

6

Dosage Form

-

Strength

2MG

Approval Date

2002-11-15

21436 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

21436

Product Number

6

Dosage Form

-

Strength

2MG

Approval Date

2002-11-15

Regulatory Status

RX

2023
27 Apr
RX Application: 217006

Drug Name

ABILIFY ASIMTUFII

Product Number

1

Dosage Form

-

Strength

720MG/2.4ML (300MG/ML)

Approval Date

2023-04-27

217006 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

217006

Product Number

1

Dosage Form

-

Strength

720MG/2.4ML (300MG/ML)

Approval Date

2023-04-27

Regulatory Status

RX

2023
27 Apr
RX Application: 217006

Drug Name

ABILIFY ASIMTUFII

Product Number

2

Dosage Form

-

Strength

960MG/3.2ML (300MG/ML)

Approval Date

2023-04-27

217006 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

217006

Product Number

2

Dosage Form

-

Strength

960MG/3.2ML (300MG/ML)

Approval Date

2023-04-27

Regulatory Status

RX

2018
23 Apr
RX Application: 204441

Drug Name

JYNARQUE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2018-04-23

204441 / 1

Active Ingredient

TOLVAPTAN

Application Number

204441

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2018-04-23

Regulatory Status

RX

2018
23 Apr
RX Application: 204441

Drug Name

JYNARQUE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2018-04-23

204441 / 2

Active Ingredient

TOLVAPTAN

Application Number

204441

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2018-04-23

Regulatory Status

RX

2018
23 Apr
RX Application: 204441

Drug Name

JYNARQUE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2018-04-23

204441 / 3

Active Ingredient

TOLVAPTAN

Application Number

204441

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2018-04-23

Regulatory Status

RX

2018
23 Apr
RX Application: 204441

Drug Name

JYNARQUE

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2018-04-23

204441 / 4

Active Ingredient

TOLVAPTAN

Application Number

204441

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2018-04-23

Regulatory Status

RX

2018
23 Apr
RX Application: 204441

Drug Name

JYNARQUE

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2018-04-23

204441 / 5

Active Ingredient

TOLVAPTAN

Application Number

204441

Product Number

5

Dosage Form

-

Strength

90MG

Approval Date

2018-04-23

Regulatory Status

RX

2015
10 Jul
RX Application: 205422

Drug Name

REXULTI

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2015-07-10

205422 / 1

Active Ingredient

BREXPIPRAZOLE

Application Number

205422

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2015-07-10

Regulatory Status

RX

2015
10 Jul
RX Application: 205422

Drug Name

REXULTI

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2015-07-10

205422 / 2

Active Ingredient

BREXPIPRAZOLE

Application Number

205422

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2015-07-10

Regulatory Status

RX

2015
10 Jul
RX Application: 205422

Drug Name

REXULTI

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2015-07-10

205422 / 3

Active Ingredient

BREXPIPRAZOLE

Application Number

205422

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2015-07-10

Regulatory Status

RX

2015
10 Jul
RX Application: 205422

Drug Name

REXULTI

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2015-07-10

205422 / 4

Active Ingredient

BREXPIPRAZOLE

Application Number

205422

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2015-07-10

Regulatory Status

RX

2015
10 Jul
RX Application: 205422

Drug Name

REXULTI

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2015-07-10

205422 / 5

Active Ingredient

BREXPIPRAZOLE

Application Number

205422

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2015-07-10

Regulatory Status

RX

2015
10 Jul
RX Application: 205422

Drug Name

REXULTI

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2015-07-10

205422 / 6

Active Ingredient

BREXPIPRAZOLE

Application Number

205422

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2015-07-10

Regulatory Status

RX

2009
19 May
RX Application: 22275

Drug Name

SAMSCA

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-05-19

22275 / 1

Active Ingredient

TOLVAPTAN

Application Number

22275

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-05-19

Regulatory Status

RX

2009
19 May
RX Application: 22275

Drug Name

SAMSCA

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2009-05-19

22275 / 2

Active Ingredient

TOLVAPTAN

Application Number

22275

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2009-05-19

Regulatory Status

RX

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    41 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
21 total
  • 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

ABILIFY

Application Number

21436

Product Number

1

Active Ingredient

ARIPIPRAZOLE

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit