JANSSEN BIOTECH RX
FDA Approved Drugs

JANSSEN BIOTECH 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 13
  • Latest Approval Date Mar 17, 2026
  • Data Source FDA
  • First Approval Date Apr 28, 2011
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RX
13
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FDA Approved Drug Records ( 13 records )
2023
11 Aug
RX Application: 216793

Drug Name

AKEEGA

Product Number

1

Dosage Form

-

Strength

500MG;EQ 50MG BASE

Approval Date

2023-08-11

216793 / 1

Active Ingredient

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Application Number

216793

Product Number

1

Dosage Form

-

Strength

500MG;EQ 50MG BASE

Approval Date

2023-08-11

Regulatory Status

RX

2023
11 Aug
RX Application: 216793

Drug Name

AKEEGA

Product Number

2

Dosage Form

-

Strength

500MG;EQ 100MG BASE

Approval Date

2023-08-11

216793 / 2

Active Ingredient

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Application Number

216793

Product Number

2

Dosage Form

-

Strength

500MG;EQ 100MG BASE

Approval Date

2023-08-11

Regulatory Status

RX

2019
12 Apr
RX Application: 212018

Drug Name

BALVERSA

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2019-04-12

212018 / 1

Active Ingredient

ERDAFITINIB

Application Number

212018

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2019-04-12

Regulatory Status

RX

2019
12 Apr
RX Application: 212018

Drug Name

BALVERSA

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2019-04-12

212018 / 2

Active Ingredient

ERDAFITINIB

Application Number

212018

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2019-04-12

Regulatory Status

RX

2019
12 Apr
RX Application: 212018

Drug Name

BALVERSA

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2019-04-12

212018 / 3

Active Ingredient

ERDAFITINIB

Application Number

212018

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2019-04-12

Regulatory Status

RX

2018
14 Feb
RX Application: 210951

Drug Name

ERLEADA

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2018-02-14

210951 / 1

Active Ingredient

APALUTAMIDE

Application Number

210951

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2018-02-14

Regulatory Status

RX

2023
17 Feb
RX Application: 210951

Drug Name

ERLEADA

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2023-02-17

210951 / 2

Active Ingredient

APALUTAMIDE

Application Number

210951

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2023-02-17

Regulatory Status

RX

2026
17 Mar
RX Application: 220149

Drug Name

ICOTYDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2026-03-17

220149 / 1

Active Ingredient

ICOTROKINRA HYDROCHLORIDE

Application Number

220149

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2026-03-17

Regulatory Status

RX

2025
09 Sep
RX Application: 219683

Drug Name

INLEXZO

Product Number

1

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2025-09-09

219683 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

219683

Product Number

1

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2025-09-09

Regulatory Status

RX

2024
19 Aug
RX Application: 219008

Drug Name

LAZCLUZE

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-08-19

219008 / 1

Active Ingredient

LAZERTINIB MESYLATE

Application Number

219008

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2024-08-19

Regulatory Status

RX

2024
19 Aug
RX Application: 219008

Drug Name

LAZCLUZE

Product Number

2

Dosage Form

-

Strength

EQ 240MG BASE

Approval Date

2024-08-19

219008 / 2

Active Ingredient

LAZERTINIB MESYLATE

Application Number

219008

Product Number

2

Dosage Form

-

Strength

EQ 240MG BASE

Approval Date

2024-08-19

Regulatory Status

RX

2011
28 Apr
RX Application: 202379

Drug Name

ZYTIGA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-04-28

202379 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

202379

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2011-04-28

Regulatory Status

RX

2017
14 Apr
RX Application: 202379

Drug Name

ZYTIGA

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-04-14

202379 / 2

Active Ingredient

ABIRATERONE ACETATE

Application Number

202379

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-04-14

Regulatory Status

RX

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Drug Status Breakdown
13 total
  • 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

AKEEGA

Application Number

216793

Product Number

1

Active Ingredient

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Dosage Form

-

Strength

500MG;EQ 50MG BASE

FDA Approved Drug Data

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