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Synopsis
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22163
Submission : 2008-10-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25698
Submission : 2011-12-30
Status : Inactive
Type : II
About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...
About the Company : Kexing Biopharmaceuticals is a forward-thinking biopharmaceutical company primarily dedicated to research and development (R&D), manufacturing, and sales of recombinant protein the...
About the Company : KinBio is a rapidly growing biopharmaceutical company based in Rehovot, Israel, with its main focus on developing needed therapies as well as offering a wide range of CDMO services...
Regulatory Info :
Registration Country : USA
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 10,000U/ML
Packaging :
Approval Date :
Application Number : 103234
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; MULTIDOSE
Dosage Strength : 20,000U/2ML
Packaging :
Approval Date :
Application Number : 103234
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; MULTIDOSE
Dosage Strength : 20,000/ML
Packaging :
Approval Date :
Application Number : 103234
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 2,000U/ML
Packaging :
Approval Date :
Application Number : 103234
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 3,000U/ML
Packaging :
Approval Date :
Application Number : 103234
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 40,000U/ML
Packaging :
Approval Date :
Application Number : 103234
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 4,000U/ML
Packaging :
Approval Date :
Application Number : 103234
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2,000UNITS/ML
Packaging :
Approval Date :
Application Number : 125545
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 3,000UNITS/ML
Packaging :
Approval Date :
Application Number : 125545
Regulatory Info :
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4,000UNITS/ML
Packaging :
Approval Date :
Application Number : 125545
Regulatory Info :
Registration Country : USA
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 10,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; MULTIDOSE
Dosage Strength : 20,000U/2ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; MULTIDOSE
Dosage Strength : 20,000/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 2,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 3,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : EPOGEN/PROCRIT
Dosage Form : VIAL; SINGLE-USE
Dosage Strength : 40,000U/ML
Approval Date :
Application Number : 103234
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 2,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 3,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 4,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RETACRIT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10,000UNITS/ML
Approval Date :
Application Number : 125545
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Retacrit
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 5000IU
Packaging :
Approval Date : 2008-02-27
Application Number : 07431010
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Eporatio
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 1000IU
Packaging :
Approval Date : 2009-11-25
Application Number : 09573002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Eporatio
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 20000IU
Packaging :
Approval Date : 2009-11-25
Application Number : 09573018
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Eporatio
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 30000IU
Packaging :
Approval Date : 2015-06-24
Application Number : 109573040
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Eporatio
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 1000IU
Packaging :
Approval Date : 2009-11-25
Application Number : 09573001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Eporatio
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 4000IU
Packaging :
Approval Date : 2009-11-25
Application Number : 09573007
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Eporatio
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 3000IU
Packaging :
Approval Date : 2009-11-25
Application Number : 09573006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Binocrit
Dosage Form : Injectable In Pre-Filled Syringe
Dosage Strength : 30000IU
Packaging :
Approval Date : 2009-12-22
Application Number : 07410024
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Binocrit,
Dosage Form : Injectable Solution In A Pre-Filled Syringe
Dosage Strength : 7000IU
Packaging :
Approval Date : 2008-10-27
Application Number : 07410018
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Binocrit,
Dosage Form : Injectable Solution In A Pre-Filled Syringe
Dosage Strength : 6000IU
Packaging :
Approval Date : 2008-02-18
Application Number : 07410012
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Novicrit
Dosage Form :
Dosage Strength :
Packaging : 6
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon 10000 Penfill
Dosage Form : INJ
Dosage Strength : 10000iu
Packaging : 84X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon 20000 Penfill
Dosage Form : INJ
Dosage Strength : 20000iu
Packaging : 84X4mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon Pre-Filled
Dosage Form : PFS
Dosage Strength : 6000iu
Packaging : 0.3X6iu
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon Pre-Filled
Dosage Form : PFS
Dosage Strength : 4000iu
Packaging : 0.3X6iu
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon Pre-Filled
Dosage Form : PFS
Dosage Strength : 2000iu
Packaging : 0.3X6iu
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon Pre-Filled
Dosage Form : PFS
Dosage Strength : 10000iu
Packaging : 0.3X6iu
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon 2000Iu
Dosage Form : INJ
Dosage Strength : 2000u
Packaging : 40X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon Vials
Dosage Form : INJ
Dosage Strength : 1000iu
Packaging : 5X50mg/5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Recormon 5000
Dosage Form : INJ
Dosage Strength : 5000u
Packaging : 5X50mg/5ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Eprex 6 000 I.U./0,6 ml
Dosage Form : INJ
Dosage Strength : 6000iu/0.6ml
Packaging : 0.6X6iu/0.6ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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