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01 1Akorn Pharmaceuticals

02 1Amphastar Pharmaceuticals

03 2Bausch & Lomb Incorporated

04 1Centocor

05 2Genentech

06 1Halozyme Therapeutics

07 1Xixia Pharmaceuticals (Pty) Ltd

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PharmaCompass

01

FCE Pharma
Not Confirmed
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FCE Pharma
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HYALURONIDASE

Brand Name : HYDASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150 UNITS/ML

Packaging :

Approval Date :

Application Number : 21716

Regulatory Info :

Registration Country : USA

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02

FCE Pharma
Not Confirmed
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FCE Pharma
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HYALURONIDASE

Brand Name : AMPHADASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150 UNITS/ML

Packaging :

Approval Date :

Application Number : 21665

Regulatory Info :

Registration Country : USA

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03

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

HYALURONIDASE

Brand Name : VITRASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6,200 UNITS/VIAL

Packaging :

Approval Date :

Application Number : 21640

Regulatory Info :

Registration Country : USA

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04

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

HYALURONIDASE

Brand Name : VITRASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 200 UNITS/VIAL

Packaging :

Approval Date :

Application Number : 21640

Regulatory Info :

Registration Country : USA

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05

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

DARATUMUMAB AND HYALURONIDASE-FIHJ

Brand Name : DARZALEX FASPRO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 120MG;2000UNITS/ML

Packaging :

Approval Date :

Application Number : 761145

Regulatory Info :

Registration Country : USA

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06

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF

Brand Name : PHESGO

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 1,200MG;600MG;30,000UNITS

Packaging :

Approval Date :

Application Number : 761170

Regulatory Info :

Registration Country : USA

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07

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF

Brand Name : PHESGO

Dosage Form : INJECTABLE;SUBCUTANEOUS

Dosage Strength : 600MG;600MG;20,000UNITS

Packaging :

Approval Date :

Application Number : 761170

Regulatory Info :

Registration Country : USA

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08

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

HYALURONIDASE RECOMBINANT HUMAN

Brand Name : HYLENEX RECOMBINANT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150 UNITS/ML

Packaging :

Approval Date :

Application Number : 21859

Regulatory Info :

Registration Country : USA

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09

Xixia Pharmaceuticals (Pty) Ltd

Country
FCE Pharma
Not Confirmed
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Xixia Pharmaceuticals (Pty) Ltd

Country
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FCE Pharma
Not Confirmed

Hyaluronidase 1,500 i.u.

Brand Name : Hyalase

Dosage Form : INJ

Dosage Strength : 1500u.i.

Packaging : 1X10u.i.

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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