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01 3Accord BioPharma
02 2Alvotech
03 9Amgen Inc
04 2Biocon Biologics
05 3CELLTRION INC.
06 3Celltrion
07 9Centocor
08 3Fresenius Kabi Austria
09 2JAMP PHARMA
10 13Janssen-Cilag
11 21Johnson & Johnson Innovative Medicine
12 2STADA Arzneimittel
13 3Samsung Bioepis
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01 1INJ
02 2INJECTABLE; INJECTION
03 7INJECTABLE;INJECTION
04 4INJECTABLE;INTRAVENOUS
05 3INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
06 3INJECTABLE;SUBCUTANEOUS
07 1Inf Conc
08 5Inj L?s
09 2PFS
10 20SOLUTION
11 2SOLUTION FOR INJECTION
12 2SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
13 2Solution for injection, solution in pre-filled syringe
14 2Ustekinumab 45Mg 0,5Ml 1 Unit Parenteral Use
15 1Ustekinumab 90Mg 1Ml 1 Units Parenteral Use
16 18Blank
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01 3Originator
02 72Blank
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01 2FINLIUS
02 1FINLIUS I.V.
03 3IMULDOSA
04 2JAMTEKI
05 2OTULFI
06 1OTULFI I.V.
07 3PYZCHIVA
08 2SELARSDI
09 9STELARA
10 1STELARA I.V.
11 5STEQEYMA
12 1STEQEYMA IV
13 27Stelara
14 1Stelara 130 mg
15 1Stelara 45 Mg
16 1Stelara 90 mg
17 2Uzpruvo
18 8WEZLANA
19 1WEZLANA I.V.
20 2YESINTEK
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01 18Australia
02 20Canada
03 3Italy
04 2Norway
05 3South Africa
06 4Sweden
07 6Switzerland
08 19USA
Regulatory Info :
Registration Country : USA
Brand Name : IMULDOSA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761364
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMULDOSA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761364
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : IMULDOSA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761364
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : SELARSDI
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761343
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : SELARSDI
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761343
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : WEZLANA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761285
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : WEZLANA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761285
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : WEZLANA
Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761331
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : YESINTEK
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761406
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : YESINTEK
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761406
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STEQEYMA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761338
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STEQEYMA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761338
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STEQEYMA
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761338
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STELARA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 125261
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STELARA
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 90MG/1ML
Packaging :
Approval Date :
Application Number : 125261
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : STELARA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 130MG/26ML
Packaging :
Approval Date :
Application Number : 761044
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : STELARA
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 45 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : USA
Brand Name : PYZCHIVA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 45MG/0.5ML
Packaging :
Approval Date :
Application Number : 761373
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : PYZCHIVA
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 90MG/ML
Packaging :
Approval Date :
Application Number : 761373
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : PYZCHIVA
Dosage Form : INJECTABLE;SUBCUTANEOUS
Dosage Strength : 130MG/26ML(5MG/ML)
Packaging :
Approval Date :
Application Number : 761425
Regulatory Info :
Registration Country : USA