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01 3Accord BioPharma

02 2Alvotech

03 9Amgen Inc

04 2Biocon Biologics

05 6Celltrion

06 9Centocor

07 2JAMP PHARMA

08 13Janssen-Cilag

09 21Johnson & Johnson Innovative Medicine

10 2STADA Arzneimittel

11 3Samsung Bioepis

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PharmaCompass

01

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-SRLF

Brand Name : IMULDOSA

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 45MG/0.5ML

Packaging :

Approval Date :

Application Number : 761364

Regulatory Info :

Registration Country : USA

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02

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-SRLF

Brand Name : IMULDOSA

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 90MG/ML

Packaging :

Approval Date :

Application Number : 761364

Regulatory Info :

Registration Country : USA

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03

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-SRLF

Brand Name : IMULDOSA

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 130MG/26ML

Packaging :

Approval Date :

Application Number : 761364

Regulatory Info :

Registration Country : USA

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04

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-AEKN

Brand Name : SELARSDI

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 45MG/0.5ML

Packaging :

Approval Date :

Application Number : 761343

Regulatory Info :

Registration Country : USA

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05

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-AEKN

Brand Name : SELARSDI

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 90MG/ML

Packaging :

Approval Date :

Application Number : 761343

Regulatory Info :

Registration Country : USA

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06

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-AUUB

Brand Name : WEZLANA

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 45MG/0.5ML

Packaging :

Approval Date :

Application Number : 761285

Regulatory Info :

Registration Country : USA

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07

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-AUUB

Brand Name : WEZLANA

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 90MG/ML

Packaging :

Approval Date :

Application Number : 761285

Regulatory Info :

Registration Country : USA

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08

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-AUUB

Brand Name : WEZLANA

Dosage Form : INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

Dosage Strength : 130MG/26ML

Packaging :

Approval Date :

Application Number : 761331

Regulatory Info :

Registration Country : USA

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09

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-KFCE

Brand Name : YESINTEK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 45MG/0.5ML

Packaging :

Approval Date :

Application Number : 761406

Regulatory Info :

Registration Country : USA

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10

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-KFCE

Brand Name : YESINTEK

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 90MG/ML

Packaging :

Approval Date :

Application Number : 761406

Regulatory Info :

Registration Country : USA

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11

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-STBA

Brand Name : STEQEYMA

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 45MG/0.5ML

Packaging :

Approval Date :

Application Number : 761338

Regulatory Info :

Registration Country : USA

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12

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-STBA

Brand Name : STEQEYMA

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 90MG/ML

Packaging :

Approval Date :

Application Number : 761338

Regulatory Info :

Registration Country : USA

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13

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-STBA

Brand Name : STEQEYMA

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 130MG/26ML

Packaging :

Approval Date :

Application Number : 761338

Regulatory Info :

Registration Country : USA

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14

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB

Brand Name : STELARA

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 45MG/0.5ML

Packaging :

Approval Date :

Application Number : 125261

Regulatory Info :

Registration Country : USA

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15

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB

Brand Name : STELARA

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 90MG/1ML

Packaging :

Approval Date :

Application Number : 125261

Regulatory Info :

Registration Country : USA

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16

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB

Brand Name : STELARA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 130MG/26ML

Packaging :

Approval Date :

Application Number : 761044

Regulatory Info :

Registration Country : USA

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17

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

ustekinumab

Brand Name : STELARA

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 45 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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18

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-TTWE

Brand Name : PYZCHIVA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 45MG/0.5ML

Packaging :

Approval Date :

Application Number : 761373

Regulatory Info :

Registration Country : USA

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19

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-TTWE

Brand Name : PYZCHIVA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 90MG/ML

Packaging :

Approval Date :

Application Number : 761373

Regulatory Info :

Registration Country : USA

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20

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

USTEKINUMAB-TTWE

Brand Name : PYZCHIVA

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 130MG/26ML(5MG/ML)

Packaging :

Approval Date :

Application Number : 761425

Regulatory Info :

Registration Country : USA

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