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01 2ABIRATERONE ACETATE
02 2ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
03 5AMIVANTAMAB AND HYALURONIDASE-LPUJ
04 1AMIVANTAMAB-VMJW
05 2APALUTAMIDE
06 2DARATUMUMAB
07 1DARATUMUMAB AND HYALURONIDASE-FIHJ
08 3ERDAFITINIB
09 1GEMCITABINE HYDROCHLORIDE
10 1GOLIMUMAB
11 1GUSELKUMAB
12 1ICOTROKINRA HYDROCHLORIDE
13 2LAZERTINIB MESYLATE
14 2NIPOCALIMAB-AAHU
15 2TALQUETAMAB-TGVS
16 2TECLISTAMAB-CQYV
17 1USTEKINUMAB
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01 31JANSSEN BIOTECH
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01 1INJECTABLE; INJECTION
02 12INJECTABLE;INJECTION
03 1INJECTION
04 1SYSTEM;INTRAVESICAL
05 12TABLET;ORAL
06 4VIAL; SINGLE-USE
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01 11,600MG/20,000 UNITS PER 10ML
02 1100MG/5ML
03 1100MG/ML
04 11200MG/6.5ML(185MG/ML)
05 1120MG;2000UNITS/ML
06 1130MG/26ML
07 114ML
08 1153MG/1.7ML(90MG/ML)
09 12,240MG/28,000 UNITS PER 14ML
10 12,400MG/30,000 UNITS PER 15ML
11 1240MG
12 1250MG
13 13,5200MG/44,000 UNITS PER 22ML
14 1300MG/1.62ML(185MG/ML)
15 130MG/3ML(10MG/ML)
16 1350MG/7ML(50MG/ML)
17 13MG
18 13MG/1.5ML(2MG/ML)
19 1400MG/20ML
20 140MG/ML
21 14MG
22 1500MG
23 1500MG;EQ 100MG BASE
24 1500MG;EQ 50MG BASE
25 150MG/4ML
26 15MG
27 160MG
28 1EQ 200MG BASE
29 1EQ 225MG BASE
30 1EQ 240MG BASE
31 1EQ 80MG BASE
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01 31USA
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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ZYTIGA
Dosage Strength : 250MG
Packaging :
Approval Date : 2011-04-28
Application Number : 202379
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ZYTIGA
Dosage Strength : 500MG
Packaging :
Approval Date : 2017-04-14
Application Number : 202379
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
Dosage Form : TABLET;ORAL
Brand Name : AKEEGA
Dosage Strength : 500MG;EQ 50MG BASE
Packaging :
Approval Date : 2023-08-11
Application Number : 216793
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : RX
Registration Country : USA
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
Dosage Form : TABLET;ORAL
Brand Name : AKEEGA
Dosage Strength : 500MG;EQ 100MG BASE
Packaging :
Approval Date : 2023-08-11
Application Number : 216793
Regulatory Info : RX
Registration Country : USA

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Regulatory Info :
Registration Country : USA
AMIVANTAMAB AND HYALURONIDASE-LPUJ
Dosage Form : INJECTION
Brand Name : RYBREVANT FASPRO
Dosage Strength : 14ML
Packaging :
Approval Date :
Application Number : 761433
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
AMIVANTAMAB AND HYALURONIDASE-LPUJ
Dosage Form : VIAL; SINGLE-USE
Brand Name : RYBREVANT FASPRO
Dosage Strength : 1,600MG/20,000 UNITS P...
Packaging :
Approval Date :
Application Number : 761484
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
AMIVANTAMAB AND HYALURONIDASE-LPUJ
Dosage Form : VIAL; SINGLE-USE
Brand Name : RYBREVANT FASPRO
Dosage Strength : 2,240MG/28,000 UNITS P...
Packaging :
Approval Date :
Application Number : 761484
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
AMIVANTAMAB AND HYALURONIDASE-LPUJ
Dosage Form : VIAL; SINGLE-USE
Brand Name : RYBREVANT FASPRO
Dosage Strength : 2,400MG/30,000 UNITS P...
Packaging :
Approval Date :
Application Number : 761484
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
AMIVANTAMAB AND HYALURONIDASE-LPUJ
Dosage Form : VIAL; SINGLE-USE
Brand Name : RYBREVANT FASPRO
Dosage Strength : 3,5200MG/44,000 UNITS ...
Packaging :
Approval Date :
Application Number : 761484
Regulatory Info :
Registration Country : USA

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Regulatory Info :
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : RYBREVANT
Dosage Strength : 350MG/7ML(50MG/ML)
Packaging :
Approval Date :
Application Number : 761210
Regulatory Info :
Registration Country : USA
