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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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01 1INJ
02 6INJECTABLE;INJECTION
03 2INJECTABLE;SUBCUTANEOUS
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01 1Originator
02 8Blank
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01 1AMPHADASE
02 1DARZALEX FASPRO
03 1HYDASE
04 1HYLENEX RECOMBINANT
05 1Hyalase
06 2PHESGO
07 2VITRASE
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01 1South Africa
02 8USA
Regulatory Info :
Registration Country : USA
Brand Name : HYDASE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 150 UNITS/ML
Packaging :
Approval Date :
Application Number : 21716
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : AMPHADASE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 150 UNITS/ML
Packaging :
Approval Date :
Application Number : 21665
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VITRASE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 6,200 UNITS/VIAL
Packaging :
Approval Date :
Application Number : 21640
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : VITRASE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 200 UNITS/VIAL
Packaging :
Approval Date :
Application Number : 21640
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
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
Regulatory Info :
Registration Country : USA
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
Regulatory Info :
Registration Country : USA
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
Regulatory Info :
Registration Country : USA
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
Regulatory Info : Originator
Registration Country : South Africa
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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