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01 1AKORN INC

02 1AMPHASTAR PHARM

03 2BAUSCH AND LOMB

04 2GENENTECH INC

05 1HALOZYME THERAP

06 1JANSSEN BIOTECH

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PharmaCompass

01

IOPC
Not Confirmed
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IOPC
Not Confirmed

HYALURONIDASE

Brand Name : HYDASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150 UNITS/ML

Approval Date :

Application Number : 21716

RX/OTC/DISCN :

RLD :

TE Code :

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02

IOPC
Not Confirmed
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IOPC
Not Confirmed

HYALURONIDASE

Brand Name : AMPHADASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150 UNITS/ML

Approval Date :

Application Number : 21665

RX/OTC/DISCN :

RLD :

TE Code :

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03

IOPC
Not Confirmed
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IOPC
Not Confirmed

HYALURONIDASE

Brand Name : VITRASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6,200 UNITS/VIAL

Approval Date :

Application Number : 21640

RX/OTC/DISCN :

RLD :

TE Code :

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04

IOPC
Not Confirmed
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IOPC
Not Confirmed

HYALURONIDASE

Brand Name : VITRASE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 200 UNITS/VIAL

Approval Date :

Application Number : 21640

RX/OTC/DISCN :

RLD :

TE Code :

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05

IOPC
Not Confirmed
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IOPC
Not Confirmed

DARATUMUMAB AND HYALURONIDASE-FIHJ

Brand Name : DARZALEX FASPRO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 120MG;2000UNITS/ML

Approval Date :

Application Number : 761145

RX/OTC/DISCN :

RLD :

TE Code :

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06

IOPC
Not Confirmed
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IOPC
Not Confirmed

PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF

Brand Name : PHESGO

Dosage Form : INJECTABLE;SUBCUTANEOUS

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

Approval Date :

Application Number : 761170

RX/OTC/DISCN :

RLD :

TE Code :

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07

IOPC
Not Confirmed
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IOPC
Not Confirmed

PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF

Brand Name : PHESGO

Dosage Form : INJECTABLE;SUBCUTANEOUS

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

Approval Date :

Application Number : 761170

RX/OTC/DISCN :

RLD :

TE Code :

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08

IOPC
Not Confirmed
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IOPC
Not Confirmed

HYALURONIDASE RECOMBINANT HUMAN

Brand Name : HYLENEX RECOMBINANT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 150 UNITS/ML

Approval Date :

Application Number : 21859

RX/OTC/DISCN :

RLD :

TE Code :

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