JANSSEN BIOTECH
FDA Approved Drugs

JANSSEN BIOTECH

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 Unclassified
  • Total Records 32
  • Latest Approval Date Mar 17, 2026
  • Data Source FDA
  • First Approval Date Apr 28, 2011
All
32
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Unclassified
19
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RX
13
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FDA Approved Drug Records ( 32 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

-
Unclassified Application: 761036

Drug Name

DARZALEX

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

-

761036 / 1

Active Ingredient

DARATUMUMAB

Application Number

761036

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761036

Drug Name

DARZALEX

Product Number

2

Dosage Form

-

Strength

400MG/20ML

Approval Date

-

761036 / 2

Active Ingredient

DARATUMUMAB

Application Number

761036

Product Number

2

Dosage Form

-

Strength

400MG/20ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761145

Drug Name

DARZALEX FASPRO

Product Number

1

Dosage Form

-

Strength

120MG;2000UNITS/ML

Approval Date

-

761145 / 1

Active Ingredient

DARATUMUMAB AND HYALURONIDASE-FIHJ

Application Number

761145

Product Number

1

Dosage Form

-

Strength

120MG;2000UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

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

-
Unclassified Application: 761430

Drug Name

IMAAVY

Product Number

1

Dosage Form

-

Strength

300MG/1.62ML(185MG/ML)

Approval Date

-

761430 / 1

Active Ingredient

NIPOCALIMAB-AAHU

Application Number

761430

Product Number

1

Dosage Form

-

Strength

300MG/1.62ML(185MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761430

Drug Name

IMAAVY

Product Number

2

Dosage Form

-

Strength

1200MG/6.5ML(185MG/ML)

Approval Date

-

761430 / 2

Active Ingredient

NIPOCALIMAB-AAHU

Application Number

761430

Product Number

2

Dosage Form

-

Strength

1200MG/6.5ML(185MG/ML)

Approval Date

-

Regulatory Status

Unclassified

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

-
Unclassified Application: 761210

Drug Name

RYBREVANT

Product Number

1

Dosage Form

-

Strength

350MG/7ML(50MG/ML)

Approval Date

-

761210 / 1

Active Ingredient

AMIVANTAMAB-VMJW

Application Number

761210

Product Number

1

Dosage Form

-

Strength

350MG/7ML(50MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761433

Drug Name

RYBREVANT FASPRO

Product Number

1

Dosage Form

-

Strength

10ML

Approval Date

-

761433 / 1

Active Ingredient

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Application Number

761433

Product Number

1

Dosage Form

-

Strength

10ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761433

Drug Name

RYBREVANT FASPRO

Product Number

2

Dosage Form

-

Strength

14ML

Approval Date

-

761433 / 2

Active Ingredient

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Application Number

761433

Product Number

2

Dosage Form

-

Strength

14ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761484

Drug Name

RYBREVANT FASPRO

Product Number

1

Dosage Form

-

Strength

1,600MG/20,000 UNITS PER 10ML

Approval Date

-

761484 / 1

Active Ingredient

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Application Number

761484

Product Number

1

Dosage Form

-

Strength

1,600MG/20,000 UNITS PER 10ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761484

Drug Name

RYBREVANT FASPRO

Product Number

2

Dosage Form

-

Strength

2,240MG/28,000 UNITS PER 14ML

Approval Date

-

761484 / 2

Active Ingredient

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Application Number

761484

Product Number

2

Dosage Form

-

Strength

2,240MG/28,000 UNITS PER 14ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761484

Drug Name

RYBREVANT FASPRO

Product Number

3

Dosage Form

-

Strength

2,400MG/30,000 UNITS PER 15ML

Approval Date

-

761484 / 3

Active Ingredient

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Application Number

761484

Product Number

3

Dosage Form

-

Strength

2,400MG/30,000 UNITS PER 15ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761484

Drug Name

RYBREVANT FASPRO

Product Number

4

Dosage Form

-

Strength

3,5200MG/44,000 UNITS PER 22ML

Approval Date

-

761484 / 4

Active Ingredient

AMIVANTAMAB AND HYALURONIDASE-LPUJ

Application Number

761484

Product Number

4

Dosage Form

-

Strength

3,5200MG/44,000 UNITS PER 22ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125433

Drug Name

SIMPONI ARIA

Product Number

1

Dosage Form

-

Strength

50MG/4ML

Approval Date

-

125433 / 1

Active Ingredient

GOLIMUMAB

Application Number

125433

Product Number

1

Dosage Form

-

Strength

50MG/4ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761044

Drug Name

STELARA

Product Number

1

Dosage Form

-

Strength

130MG/26ML

Approval Date

-

761044 / 1

Active Ingredient

USTEKINUMAB

Application Number

761044

Product Number

1

Dosage Form

-

Strength

130MG/26ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761342

Drug Name

TALVEY

Product Number

1

Dosage Form

-

Strength

3MG/1.5ML(2MG/ML)

Approval Date

-

761342 / 1

Active Ingredient

TALQUETAMAB-TGVS

Application Number

761342

Product Number

1

Dosage Form

-

Strength

3MG/1.5ML(2MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761342

Drug Name

TALVEY

Product Number

2

Dosage Form

-

Strength

40MG/ML

Approval Date

-

761342 / 2

Active Ingredient

TALQUETAMAB-TGVS

Application Number

761342

Product Number

2

Dosage Form

-

Strength

40MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761291

Drug Name

TECVAYLI

Product Number

1

Dosage Form

-

Strength

30MG/3ML(10MG/ML)

Approval Date

-

761291 / 1

Active Ingredient

TECLISTAMAB-CQYV

Application Number

761291

Product Number

1

Dosage Form

-

Strength

30MG/3ML(10MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761291

Drug Name

TECVAYLI

Product Number

2

Dosage Form

-

Strength

153MG/1.7ML(90MG/ML)

Approval Date

-

761291 / 2

Active Ingredient

TECLISTAMAB-CQYV

Application Number

761291

Product Number

2

Dosage Form

-

Strength

153MG/1.7ML(90MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761061

Drug Name

TREMFYA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

-

761061 / 1

Active Ingredient

GUSELKUMAB

Application Number

761061

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

-

Regulatory Status

Unclassified

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
32 total
  • RX
  • 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

AKEEGA

Application Number

216793

Product Number

1

Active Ingredient

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Dosage Form

-

Strength

500MG;EQ 50MG BASE

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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