JANSSEN BIOTECH Unclassified
FDA Approved Drugs
JANSSEN BIOTECH Unclassified
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.
- Total Records 19
- Latest Approval Date -
- Data Source FDA
- First Approval Date -
Company Snapshot
JANSSEN BIOTECH Unclassified
View on MapFDA Approved Drug Records ( 19 records )
Drug Name
DARZALEX
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
-
Active Ingredient
DARATUMUMAB
Application Number
761036
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DARZALEX
Product Number
2
Dosage Form
-
Strength
400MG/20ML
Approval Date
-
Active Ingredient
DARATUMUMAB
Application Number
761036
Product Number
2
Dosage Form
-
Strength
400MG/20ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DARZALEX FASPRO
Product Number
1
Dosage Form
-
Strength
120MG;2000UNITS/ML
Approval Date
-
Active Ingredient
DARATUMUMAB AND HYALURONIDASE-FIHJ
Application Number
761145
Product Number
1
Dosage Form
-
Strength
120MG;2000UNITS/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
IMAAVY
Product Number
1
Dosage Form
-
Strength
300MG/1.62ML(185MG/ML)
Approval Date
-
Active Ingredient
NIPOCALIMAB-AAHU
Application Number
761430
Product Number
1
Dosage Form
-
Strength
300MG/1.62ML(185MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
IMAAVY
Product Number
2
Dosage Form
-
Strength
1200MG/6.5ML(185MG/ML)
Approval Date
-
Active Ingredient
NIPOCALIMAB-AAHU
Application Number
761430
Product Number
2
Dosage Form
-
Strength
1200MG/6.5ML(185MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RYBREVANT
Product Number
1
Dosage Form
-
Strength
350MG/7ML(50MG/ML)
Approval Date
-
Active Ingredient
AMIVANTAMAB-VMJW
Application Number
761210
Product Number
1
Dosage Form
-
Strength
350MG/7ML(50MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RYBREVANT FASPRO
Product Number
1
Dosage Form
-
Strength
10ML
Approval Date
-
Active Ingredient
AMIVANTAMAB AND HYALURONIDASE-LPUJ
Application Number
761433
Product Number
1
Dosage Form
-
Strength
10ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RYBREVANT FASPRO
Product Number
2
Dosage Form
-
Strength
14ML
Approval Date
-
Active Ingredient
AMIVANTAMAB AND HYALURONIDASE-LPUJ
Application Number
761433
Product Number
2
Dosage Form
-
Strength
14ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RYBREVANT FASPRO
Product Number
1
Dosage Form
-
Strength
1,600MG/20,000 UNITS PER 10ML
Approval Date
-
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
Drug Name
RYBREVANT FASPRO
Product Number
2
Dosage Form
-
Strength
2,240MG/28,000 UNITS PER 14ML
Approval Date
-
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
Drug Name
RYBREVANT FASPRO
Product Number
3
Dosage Form
-
Strength
2,400MG/30,000 UNITS PER 15ML
Approval Date
-
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
Drug Name
RYBREVANT FASPRO
Product Number
4
Dosage Form
-
Strength
3,5200MG/44,000 UNITS PER 22ML
Approval Date
-
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
Drug Name
SIMPONI ARIA
Product Number
1
Dosage Form
-
Strength
50MG/4ML
Approval Date
-
Active Ingredient
GOLIMUMAB
Application Number
125433
Product Number
1
Dosage Form
-
Strength
50MG/4ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
STELARA
Product Number
1
Dosage Form
-
Strength
130MG/26ML
Approval Date
-
Active Ingredient
USTEKINUMAB
Application Number
761044
Product Number
1
Dosage Form
-
Strength
130MG/26ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TALVEY
Product Number
1
Dosage Form
-
Strength
3MG/1.5ML(2MG/ML)
Approval Date
-
Active Ingredient
TALQUETAMAB-TGVS
Application Number
761342
Product Number
1
Dosage Form
-
Strength
3MG/1.5ML(2MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TALVEY
Product Number
2
Dosage Form
-
Strength
40MG/ML
Approval Date
-
Active Ingredient
TALQUETAMAB-TGVS
Application Number
761342
Product Number
2
Dosage Form
-
Strength
40MG/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TECVAYLI
Product Number
1
Dosage Form
-
Strength
30MG/3ML(10MG/ML)
Approval Date
-
Active Ingredient
TECLISTAMAB-CQYV
Application Number
761291
Product Number
1
Dosage Form
-
Strength
30MG/3ML(10MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TECVAYLI
Product Number
2
Dosage Form
-
Strength
153MG/1.7ML(90MG/ML)
Approval Date
-
Active Ingredient
TECLISTAMAB-CQYV
Application Number
761291
Product Number
2
Dosage Form
-
Strength
153MG/1.7ML(90MG/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TREMFYA
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
-
Active Ingredient
GUSELKUMAB
Application Number
761061
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
-
Regulatory Status
Unclassified
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Drug Status Breakdown
19 total- Unclassified
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
Visit FDA Orange BookFDA Approved Drug Record Details Preview
Explore important FDA approved drug information available in the records above.
Drug Name
DARZALEX
Application Number
761036
Product Number
1
Active Ingredient
DARATUMUMAB
Dosage Form
-
Strength
100MG/5ML
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